Exposing the LASIK Scam

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.

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.

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.

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.

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. "

http://www.accessdata.fda.gov/scripts/c ... _ID=916768

http://www.accessdata.fda.gov/scripts/c ... _ID=908570

http://www.accessdata.fda.gov/scripts/c ... _ID=907878

http://www.accessdata.fda.gov/scripts/c ... _ID=885873

http://www.accessdata.fda.gov/scripts/c ... _ID=873539

http://www.accessdata.fda.gov/scripts/c ... _ID=873551

http://www.accessdata.fda.gov/scripts/c ... _ID=873552

http://www.accessdata.fda.gov/scripts/c ... _ID=861058

http://www.accessdata.fda.gov/scripts/c ... _ID=861060

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.