Exposing the LASIK Scam

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PostPosted: Mon Dec 12, 2005 12:46 pm 
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http://www.accessdata.fda.gov/scripts/c ... Search.cfm

Type in "Intralase" for the brand name to pull up MDRs filed on Intralase. The product code is GEX but you will get other reports not related to Intralase.

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PostPosted: Mon Dec 12, 2005 12:47 pm 
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From the MDRs:

http://www.accessdata.fda.gov/scripts/c ... _ID=437618

THE INTRALASE FS LASER WAS USED TO CREATE A CORNEAL FLAP FOR BILATERAL MONOVISION LASIK SURGERY. THE FLAPS ON BOTH EYES WERE CREATED SUCCESSFULLY. AFTER THE FLAP WAS CREATED ON THE SECOND (LEFT) EYE, THE SUCTION WAS RELEASED AND THE SUCTION RING ASSEMBLY WAS REMOVED FROM THE EYE. THE BEAM DELIVERY DEVICE (BDD) WAS LIFTED OFF THE EYE WHILE THE SURGEON REPLACED THE CORNEAL FLAP. WHILE THE BDD WAS MOVING UPWARDS, DOWNWARD MOTION WAS INADVERTENTLY INITIATED. THE SURGEON AND ASSISTING SURGEON ATTEMPTED TO REVERSE DIRECTION OF THE BDD USING THE JOYSTICK, HOWEVER THE JOYSTICK BROKE OFF OF THE UNIT AS A RESULT OF EXCESSIVE FORCE. THE BDD DID NOT CONTACT THE EYE, BUT DID MAKE CONTACT WITH THE PT'S LEFT TEMPORAL PERIORBITAL AREA. THERE WAS NO VISIBLE OR DISCERNABLE INJURY TO THE PT, I.E., LESIONS OR CONTUSIONS; HOWEVER, AT THE 10-DAY POST-OPERATIVE VISIT, MILD YELLOWING IN THE AREA WAS NOTED BY THE SURGEON, INDICATING THAT BRUISING HAD OCCURRED. NO CONTACT WAS MADE WITH THE EYE, AND THE PT'S UNCORRECTED VISUAL ACUITY IMPROVED FROM 20/400 PRE-OPERATIVELY TO 20/70 ON THE FIRST DAY OF POST-OPERATIVE.

http://www.accessdata.fda.gov/scripts/c ... _ID=428421

THE JOYSTICK OF THE INTRALASE FS LASER WAS NOT WORKING PROPERLY. THE JOYSTICK, WHICH CONTROLS MOVEMENT OF THE DELIVERY SYSTEM, MOVED IN THE OPPOSITE DIRECTION. SPECIFICALLY, WHEN DOWNWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED UP; AND WHEN UPWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED DOWN. THIS MALFUNCTION WAS DETECTED PRIOR TO SURGERY, THERE WAS NO PATIENT INVOLVEMENT OR INJURY. UPWARD MOVEMENT DOES NOT POSE ANY PATIENT RISK, HOWEVER UNANTICIPATED DOWNWARD MOVEMENT OF THE DELIVERY SYSTEM HAS THE POTENTIAL TO CAUSE CORNEAL TRAUMA.

http://www.accessdata.fda.gov/scripts/c ... _ID=427562

DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP AND THE INTRALASE FS DISPOSABLE PATIENT INTERFACE (PI) WAS USED TO APPLANATE THE CORNEA PRIOR TO FLAP CREATION. DURING FLAP CREATION, THERE WAS A SMALL AREA OF INEFFECTIVE PHOTODISRUPTION THAT REQUIRED ADDITIONAL MANIPULATION TO LIFT THE FLAP. THIS EVENT DID NOT RESULT IN ANY PATIENT INJURY AND THE PATIENT'S POST-OPERATIVE VISUAL ACUITY IS 20/20. AFTER REVIEWING A VIDEOTAPE OF THE SURGERY, THE SURGEON NOTICED THERE WAS A POSSIBLE DEFECT ON THE SURFACE OF THE PATIENT INTERFACE APPLANATION LENS. THE POSSIBLE LENS DEFECT WAS IN THE SAME LOCATION AS THE AREA OF INEFFECTIVE PHOTODISRUPTION. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL TEAR AND POSSIBLE SURGICAL INTERVENTION.

http://www.accessdata.fda.gov/scripts/c ... _ID=427566

DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP. DURING THE PROCEDURE, A SCREW HAD LOOSENED FROM THE DELIVERY SYSTEM AREA AND THE WASHER LANDED ON THE PATIENT'S FOREHEAD. THE PATIENT WAS NOT INJURED AND THE SURGERY CONTINUED WITHOUT INCIDENT. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL ABRASION AND POSSIBLE SURGICAL INTERVENTION.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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http://www.accessdata.fda.gov/scripts/c ... _ID=483344

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 09/12/2003 MDR TEXT KEY: 1674969 Patient Sequence Number: 1
SUBSEQUENT TO LASIK SURGERY WITH THE INTRALASE FS LASER, THE PT'S VISUAL RECOVERY HAS BEEN DELAYED. THE SURGERY WAS UNEVENTFUL, HOWEVER, POSTOPERATIVELY, THE SURGEON OBSERVED WHAT HE DESCRIBED AS AN "ORANGE PEEL EFFECT" WITH DELAYED VISUAL RECOVERY. PREOPERATIVELY, THE PT'S BEST CORRECTED VISULA ACULTY (BCVA) WAS 20/20 IN BOTH EYES. AT THE 19-DAY POSTOPERATIVE VISIT, THE PT'S BCVA WAS 20/30 OD AND 20/60 OS. AT THE 2-MONTH POSTOPERATIVE VISIT, THE PT'S BCVA IMPROVED TO 20/25 OD. HOWEVER THE OS EYE WAS 20/50. THERE HAVE BEEN NO SECONDARY SURGICAL INTERVENTIONS PERFORMED AT THIS TIME.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Dec 12, 2005 12:48 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=475323

THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAPS FOR BILATERAL LASIK SURGERY IN 2003. A 120 MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER, HOWEVER WHEN THE SURGEON ATTEMPTED TO LIFT THE FLAP (IN THE OS EYE) WITH A SLADE SPATULA, HE CREATED A FALSE CHANNEL WITH THE SPATULA. THE SURGEON THEN INTRODUCED THE SPALULA FROM THE OPPOSITE SIDE AND THE FLAP LIFTED SUCCESSFULLY AND THE EXCIMER TREATMENT WAS PERFORMED. AT THE ONE DAY POSTOP VISIT, THE PATIENT PRESENTED WITH FLAP EDEMA, HAZO, RIDGES, AND BLURRY VISION. THE PATIENT WAS RETERRED TO A CORNEAL SPECIALIST FOR POSTOPERATIVE FOLLOW-UP. AT THE ONE-MONTH POSTOPERATIVE VISIT. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (DCVA) IN THE AFFECTED (OS) EYE WAS 20/200, COMPARED WITH THE PATIENT'S PREOPERATIVE BCVA OF 20/20).


http://www.accessdata.fda.gov/scripts/c ... _ID=474912

SUBSEQUENT TO LASIK SURGERY WITH USE OF THE INTRALASE FS LASER TO CREATE THE CORNEAL FLAP, A PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATATIS (DLK) BILATERALLY. AT APPROXIMATELY ONE WEEK POSTOPERATIVELY, THE DLK HAD PROGRESSED TO STAFE IV AND CENTRAL FOLDS WERE OBSERVED. THE PATIENT WAS TREATED WITH TOPICAL STERIODS; HOWEVER THE FLAPS WERE NOT LITTED OR RINSED. AT THE 3 WEEK POSTOPERATIVE VISIT, THE PATIENT'S BEST CORRECTED VISUAL ACUITY HAD DECREASED MORE THAN 2 LINES AND RESULTED IN INDUCED ASTIGMATISM.

http://www.accessdata.fda.gov/scripts/c ... _ID=474978

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646970 Patient Sequence Number: 1
THE INTRALASE FS LASER AND INTRALASE PATIENT INTERFACE WERE USED TO CREATE THE CORNEAL FLAPS FOR BILATERIAL LASIK SURGEON. DURING SURGERY ON TEH OS EYE, THE DISSECTION WAS INCOMPLETE AND RESULTED IN A TORN CORNEAL FLAP. THE INCOMPLETE DISSECTION WAS LATER ATTRIBUTED TO A BENT PATIENT INTERFACE CONE. THE LASIK SURGERY WAS THEN PERFORMED SUCCESSFULLY AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE AFFECTED EYE WAS 20/25 AT THE ONE WEEK POSTOPERATIVE VISIT. THE PATIENT'S PREOPERATIVE BCVA WAS 20/20. ALL THE TIME OF THE COMPLAINT CLOSURE, THE PATIENT'S BCVA IMPROVED TO 20/20 AT THE 3 MONTH POSTOPERATIVE VISIT. 6 MONTHS LATER INTRALASE WAS NOTIFIED THAT THIS PATIENT HAD LASIK ENHANCEMENT PERFORMED ON BOTH EYES, THE ENHANCEMENT PROCEDURE WAS NOT PERFORMED AS A RESULT OF THE COMPLICATION. DURING THE ENHANCEMENT ON THE OS EYE, A 160-MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER. THE SURGEON OBSERVED GAS BUBBLES FORMING UNDER THE PREVIOUS FLAP, SO HE WAITED 5 HOURS AND THEN CRCATED A SECOND FLAP AT A DEPTN TO 200 MICRONS. THE FLAP WAS LIFTED SUCCESSFULLY AND THE EXCIMER ABLATION WAS PERFORMED. AT THE PATIENT'S MOST RECENT POSTOPERATIVE VISIT, THE BCVA IN OS EYE HAD DECREASED FROM 20/20 PREOPERATIVELY TO 20/50 AND IRREGULAR ASTIGMATISM WAS OBSERVED. THE SURGEON IS CONSIDERING PERFORMING A CUSTOM EXCIMER TREATMENT.


ADDITIONAL MANUFACTURER NARRATIVE
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646973
THE INIRALASE PATIENT INTERFACE CONE WAS RETURNED TO INTRALASE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION REVEALED THAT THE CONE DID NOT MEET SPECIFICATIONS. ONE OF THE FOUR CONE LEGS WAS SLIGHTLY BENT.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sat Apr 01, 2006 2:21 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=637281


"It was reported to intralase that subsequent to bilateral "bladeless" lasik, the pt developed severe "dlk," which was treated with long-term topical and oral steroids. Posterior subcapsular cataracts formed and intrastromal scarring resulted. Cataract surgery will be performed to prevent permanent impairment. It should be noted that the reporting physician assumed this pt's follow-up care and was not the surgeon who performed the lasix procedure. "

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:52 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=916768

Quote:
The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 on patient's left (os) eye. The doctor reported he experienced a difficult flap lift, excessive opaque bubble layer (obl) and centration difficulties as patient had loose epithelium. A bandage contact lens (bcl) was placed due to an irregular corneal surface. The patient's preoperative best corrected visual acuity (bcva) was 20/20-2 os. Patient's postoperative bcva is 20/60 os. Current bcva has been requested from the facility, but information has not been provided as of 9/21/07. If additional information becomes available, a supplemental report will be submitted. The association between the event and the device is unknown.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:54 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=908570

Quote:
Manufacturer Narrative
An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas visited the site in 2007 and performed an investigation. In summary, the probable root cause appears to be associated with the site not draining their sterilizer regularly. The cas advised site regarding sterilization practices and the site has since changed their statim 2000 sterilizer to a graham autoclave sterilizer. In addition, surgical instruments are now put in an ultrasonic cleaner, packaged, and then autoclaved. Dlk has resolved since noted changes were implemented.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. Postoperatively (eight days later) the patient was presented with central diffuse lamellar keratitis (dlk) in both eyes (ou). The right (od) eye with stage 2+ dlk and the left (os) with 4+ dlk and slight corneal melting. A flap lift and rinse was performed on left eye only. The patient was treated with steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20. Patient's postoperative bcva is 20/30 +0. 25+0. 25x115 os with mild haze and 20/20 od. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:55 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=907878

Quote:
Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the next day) the patient presented with diffuse lamellar keratosis (dlk) and central striae. The following month, the patient was diagnosed with central toxic keratopathy (ctk), slight central corneal melting on the left (os) eye and doctor opted to perform a flap lift and rinse on both (ou) eyes. The patient was prescribed with topical steroids and has responded to treatment. The patient's preoperative best corrected visual acuity (bcva) want 20/20 ou. Patient's postoperative bcva is 20/20 od and 20/25+2 os. Dlk and ctk have resolved. The association between the event and the device is unknown.


Manufacturer Narrative
An intralase clinical applications specialist (cas) provided surgery support in 2007, and has been in contact with the physician obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas and physician believe that the cause of dlk is due to something in the surgical suite environment. The site has recently changed their air filter, started using a disposable canulas, and changed their cleaning solution for the instruments. After implementing these changes, the hospital has noticed a significant improvement in patient outcomes. An intralase field service engineer (fse) performed preventive maintenance on july 25, 2007 and the laser system met specifications and performed as intended.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:56 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=885873

Quote:
Manufacturer Narrative
On 07/2007, an intralase field service manager visited the site, provided surgery support and performed preventative maintenance. The laser system was assessed, and met all specifications and performed as intended. There were no issues observed during surgery support.

Event Description
The intralase fs laser was used to create bilateral corneal flaps lasik surgery in 2007. During surgery, the flap on the left eye (os) became decentered. Postoperatively, the pt presented with mild microstriae os and the following month, intervention was performed to lift, irrigate, and smooth the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in both eyes. Postoperatively, the pt's bcva is 20/16 in the left eye and 20/25 in the right eye. The association between the event and the device is unk.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:57 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=873539

Quote:
Manufacturer Narrative
In 2007, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Cas inquired into instrument and surgical preparation practices, as well as technique. The cas did not identify any unusual practices, and found the laser system met specifications and performed as intended. One day later, an intralase field service engineer (fse) visited the site, performed minor alignment of the oscillator and found the laser system met specifications and performed as intended. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create corneal bilateral flaps for lasik surgery in 2007. One week postoperatively, the pt presented with central toxic keratopathy (ctk), and stria at which time the doctor opted to perform stria removal and repositioned the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in the right (od) eye and 20/20 in the left (os) eye. The pt's current postoperative bcva is 20/30 od, 20/30 os and 20/25 in both (ou) eyes. The association between the event and the device is unknown.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:58 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=873551

Quote:
Manufacturer Narrative
On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with trace diffuse lamellar keratitis (dlk) on the right (od) eye and stage 2+ on the left (os) eye. A flap lift and rinse was performed the following day on the left (os) eye only. Pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 both (ou) eyes. Postoperative bcva is 20/100 od and 20/15-2 os. The od eye was corrected for near vision and the bcva taken was distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 8:59 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=873552

Quote:
Manufacturer Narrative
On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with 2+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed four days later, and pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) in the right (od) eye was 20/20-1 and 20/25 in the left (os) eye. Postoperative bcva is 20/20 od and 20/50 os. The os eye was corrected for near vision and the bcva taken was for distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 9:02 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=861058

Quote:
Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007, in both (ou) eyes. One day postoperatively (the followig day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20 ou. The pt's current postoperative bcva is 20/50 + od and bcva 20/30+os. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative
An field svc engineer (fse) performed preventive maintenance on 04/19/07, and the laser sys performed as intended, and met specifications. On 05/08/07, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any usual environmental or surgical technique issues.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 9:03 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=861060

Quote:
Event Description
The intralase fs laser was used to create a corneal flap for lasik surgery in 2007, in the left (os) eye. One day postoperatively (the next day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20. The pt's current postoperative bcva is 20/40. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative
On 4/19/07, a field svc engineer (fse) performed preventive maintenance, and the laser maintenance performed as intended, and met specifications. On 5/08/07, an intralase clinical application specialist (cas) visited the site, and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any unusual environmental or surgical technique issues.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sun Oct 21, 2007 9:05 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=842914

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the next day, the pt presented with stage 1+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed prior to that day. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (bcva) is 20/25 od and 20/25+2 os. The pt is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative
On 2/06/07, a field service engineer performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. On 3/15/07, an intralase clinical applications specialist (cas) visited the site and noticed the laser settings are being modified on a continuous basis, against cas' advice. The site has had on-going construction adjacent to the surgical suite since 2006. An environmental company evaluated the surgical site 1/25/07 and noted the ventilation system was not working effectively, most likely due to an improperly installed air filter. Even though the site uses powder free gloves, white powder was observed on equipment and noted in the environmental report. On 3/29/07, an intralase director of clinical support found the laser system met specifications and performed as intended. It should be noted the organizations recommends treating stages 1 & 2 dlk with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. Air filters haven't been changed as recommended by environmental company on 01/25/2007.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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