Exposing the LASIK Scam

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PostPosted: Sun Oct 21, 2007 9:07 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=843993

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Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou) and was prescribed topical and oral steriods. Two days later, the doctor performed a flap lift and rinse. Four days later, postoperative check up, the left eye (os) had progressed to stage 4 dlk. The following month, postoperative check up, dlk was resolved but central scarring present. The patient's preoperative best corrected visual acuity (bcva) was 20/16 ou. Postoperative bcva as of the same day, in the right (od) was 20/16 and 20/125 os. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unknown.


Manufacturer Narrative
In 2007, an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance-no adjustments were required. Thirteen days later, an fse returned to site due to dlk report and calibarated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas)has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was no identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

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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 9:09 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=844315

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 patient presented with stage 2 diffuse lamellar keratitis (dlk). The patient was prescribed topical and oral steroids. Two days later, the doctor performed a flap lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/12. 5 both (ou) eyes. Postoperative bcva as of the following month was 20/12. 5 ou. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative
On 3/06/07 an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance - no adjustments were required. The following month, an fse returned to site due to dlk report and calibrated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was not identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

_________________
Broken Eyes

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


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 Post subject:
PostPosted: Sun Oct 21, 2007 9:12 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=840155

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


Manufacturer Narrative
In 2007, a field service engineer inspected the laser. The laser sys met specs and performed as intended. Five days later, an intralase clinical applications specialist (cas) provided surgery support and observed mold inside the sterilizer. Cas recommended replacement with new sterilizer and site followed recommendation. Additionally, cas modified laser settings. It should be noted that the american academy of ophthalmology (aao) recommends treating stages 1 & 2 dkl with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. The physician did not follow the recommended treatment protocol.

_________________
Broken Eyes

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


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 Post subject:
PostPosted: Sun Oct 21, 2007 9:15 pm 
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Joined: Sat Nov 26, 2005 1:23 pm
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http://www.accessdata.fda.gov/scripts/c ... _ID=835599

Quote:
Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with grade 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou on the same day. Dlk seemed to progress to grade 3-4+ in the right (od) eye and grade 3+ dlk in the left (os) eye so a second lift and rinse was performed ou three days later, and a third lift and rinse was performed ou the following day. Central cornea of od began melting on the same day. Patient was treated with oral and topical steroids and a bandage contact lens was placed after the first lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (ucva) is 20/50 od and 20/20 os. The patient's next follow up visit is scheduled for approx one and a half month later. Additional information will be supplied to fda when received. The association between the event and the device is unknown.


Manufacturer Narrative
On 02/06/07, a field service engineer inspected the laser and performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. The following month, an intralase clinical applications specialist (cas) provided surgery support and observed the site has been modifying their laser settings on a continuous basis, against the advice of the cas. Additionally, the site has had on-going construction adjacent to the surgical suite since 2006 that is stirring up dust and debris in the area. An environmental company evaluated the surgical site and noted that the ventilation system was not working effectively, most likely due to an air filter that was improperly installed. White powder was observed on equipment and noted in the environmental report, even though the site uses powder free gloves.

_________________
Broken Eyes

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


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 Post subject:
PostPosted: Sun Apr 13, 2008 12:39 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.

_________________
Broken Eyes

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


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 Post subject:
PostPosted: Sun May 18, 2008 11:48 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=966623

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One week post-op (approximately a week later), patient was noted to have elevated intraocular pressure (iop) in the right (od) eye due to pigmentary glaucoma. The patient's preoperative best corrected visual acuity (bcva) was 20/15 od. Postoperatively, the patient's bcva is 20/40 od. Patient treated with medications to address the increased iop. Updated patient status was requested, but information has not been provided to filutowski eye institute by co-managed office as of approx two months later. However, if additional information becomes available, supplemental report will be submitted to fda. The association between the event and the device is unknown.

_________________
Broken Eyes

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


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