Exposing the LASIK Scam

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 Post subject: FDA MDR reports for problems/injuries by VISX laser
PostPosted: Wed Dec 14, 2005 1:22 am 
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http://www.accessdata.fda.gov/scripts/c ... _ID=567146

"Visx star 83 laser which had software to prevent "central island" complications did not prevent this complication in left eye. Pt was never told of this complication from original o. D. , or m. D. Surgeon. Pt did not find out about this complication until they went to another dr in 5/2003. Currently pt is trying to find a resolution to diplopia, and other retinal imaging issues caused by this laser and its software."

To see more MDRs (Medical Device Reports) filed with the FDA on the VISX laser, go to the following link and type in "VISX" in the "Manufacturer" field and "LZS" for the "Product Code".

http://www.accessdata.fda.gov/scripts/c ... hoptions=1

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 Post subject:
PostPosted: Mon Oct 08, 2007 1:11 am 
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VISX, INCORPORATED VISX STAR S2 IR EXCIMER LASER EXCIMER LASER SYSTEM

Model Number STAR S2 IR

Event Date 03/14/2007

Event Type Injury

Patient Outcome Other;

Event Description
The dr reported that he was not able to hear the laser pulsing near the end of a therapeutic photokeratectomy procedure and believed that the laser had stopped firing. The laser did not display any errors and indicated in that the treatment completed successfully. Against the advice of amo's sr. Technical support engineer, the dr decided to continue with an add'l 18 seconds of treatment. At the one day post operative visit, the pt was 3. 0 diopter over corrected. Review of the equipment did not detect any malfunction.


Manufacturer Narrative
Evaluation: the machine operated as intended and completed the treatment. No errors were found on the error log and no evidence that the laser misfired. Review of the computer's hard drive revealed there to be no malfunction. The incident was determined to be due to the doctor's error.

http://www.accessdata.fda.gov/scripts/c ... _ID=839944

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 Post subject:
PostPosted: Mon Oct 08, 2007 1:13 am 
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VISX, INCORPORATED VISX STAR S4 IR EXCIMER LASER EXCIMER LASER SYSTEM

Model Number STAR S4 IR

Event Date 10/24/2006

Event Type Injury

Patient Outcome Other;

Event Description
During a therapeutic photokeratectomy, the surgeon inadvertently doubled-entered the amount of cornea to be removed. The surgeon reported that after he entered the correct parameters and saved the data he observed that the data disappeared from the screen, so he repeated the entry and again saved the information. Upon examination of the patient during the first post op visit, the surgeon reported that the patient had twice the amount of tissue removed than expected and was experiencing corneal haze and a visual acuity of 20/50.


Manufacturer Narrative
Attempts were made by medical monitor to replicate the actions as described in the report and it was concluded that the doubling of the intended correction could only have occurred through a data entry error. The equipment was determined to have operated properly and no service was requested.

http://www.accessdata.fda.gov/scripts/c ... _ID=806126

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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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 Post subject:
PostPosted: Mon Oct 08, 2007 1:16 am 
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VISX INCORPORATED VISX STAR S4 IR EXCIMER LASER EXCIMER LASER SYSTEM

Model Number 0030-1479
Event Date 11/17/2006
Event Type Injury Patient Outcome Other;

Event Description
A programming error reportedly occurred resulting in the pt receiving an unexpected 5 diopters of astimagtism. The pt will be re-treated in two weeks which will correct the error. The surgeon reported that the laser worked perfectly.

Manufacturer Narrative
H3 & h6 - the equipment operated properly and no service was requested. The reporter indicated that the cause of the event was user error. No further evaluation of the equipment will be conducted.

http://www.accessdata.fda.gov/scripts/c ... _ID=795601

BE's comment: Retreating 5D of induced astigmatism after two weeks is reckless and likely caused more serious permanent injury to the patient.

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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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 Post subject:
PostPosted: Mon Oct 08, 2007 1:21 am 
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VISX LASER
Model Number S2
Patient Outcome Required Intervention;

Event Description
I had bi-lateral lasik eye surgery 01/2001. I ended up over corrected and am now hyperopic by +1. 5 to +2. 0. The flaps that were cut have micro wrinkles and one flap has a minor tear or button hole. In both eyes i suffer from starburst, halos, glare, loss of contrast, and double vision. I also suffer with painful dry eyes. This surgery has completely ruined my life. I feel very cheated that the fda continues to allow this procedure with so many people's eyes being damaged.

http://www.accessdata.fda.gov/scripts/c ... _ID=698279

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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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 Post subject:
PostPosted: Mon Oct 08, 2007 1:23 am 
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VISX CUSTOMVUE, INTRALASE

Patient Outcome Other; Required Intervention Disability

Event Description
I had visx customvue lasik with intralase in 2005. I was convinced, by a dr that i had been seeing for more than ten years, to have the surgery during a routine examination. I had been struggling with contact lenses due to my high astigmatism for years so lasik seemed like the perfect solution. I had heard so many good things about the surgery and i never imagined that my dr would mislead me. My mainifest refraction was: od -0. 25 -4. 25 x 95, os -0. 75 - 3. 25 x70. My vavescan refraction was: od +0. 3. 2 -3. 80 x 98, os -0. 52 -3. 25 x 71. My pupils were measured at 8. 3 mm twice before surgery. I was told that i was a good candidate. I do not feel that the procedure should be approved for a pt with very large pupils and such a high prescription. The computer recorded this info before treatment, however, my physician appearently felt that i was an "excellent candiate. " aside from being a bad candidate i also developed micro striae in both of my flaps which may have been caused by inflammation from the intralase laser. These folds were kept hidden from me despite my constant complaints of ghost imaging and glare. I eventually got a second opinion and underwent flap suturing with another surgeon which made my striae -and symptoms- much worse. At this point my acuity is correctable to 20/20 with glasses but my vision in low light is terrible. I also have severe dry eye after seven months which causes constant burning and discomfort.

http://www.accessdata.fda.gov/scripts/c ... _ID=697992

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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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 Post subject:
PostPosted: Fri Feb 08, 2008 10:40 pm 
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Quote:
In 2007, i had lasik surgery at the eye center performed by a dr. He used the visx star s4 excimer laser. My vision after the procedure was 20/50 for distance and unable to visualize any detail on anything within arm's reach. His explanation is that the laser overcorrected my vision because my "corneal tissues were too receptive to the laser. " i now am unable to drive at night, my depth perception is so faulty that i often stumble. My glasses are so thick, i appear cross-eyed. I got caught out after dark the other night and had the choice of sitting alone in a dark car for 30 minutes waiting for glaucoma drops to help or driving down dark roads to avoid lights, cars, and pedestrians. I see double vision starbursts at traffic lights, so i'm unable to determine which way or when to go. I can not longer tell time by my watch, check my caller id, or take my medications without my glasses or a magnifying glass. I could do these things before lasik! i can no longer drive to the store at night for a carton of milk or go to the movies. I could do these things before lasik!. Diagnosis or reason for use: laser vision correction.


http://www.accessdata.fda.gov/scripts/c ... _ID=926191

_________________
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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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