FDA Adverse Event Injury Summary report: N

NA

MDR report key: 1578295 · Received January 11, 2010

Report

Report Number
MW5014315
Event Type
Injury
Date Received
January 11, 2010
Date of Event
April 1, 2002
Report Date
January 11, 2010
Manufacturer
NA
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD LASIK PERFORMED ON BOTH EYES BY A DR AT THE FACILITY IN 2002. I DON'T REMEMBER THE EXACT DATE. SINCE THEN, I HAVE HAD AN UNCOMFORTABLY DRY EYE ON THE LEFT SIDE, AND THE VISION HAS DETERIORATED ON THE RIGHT SIDE TO THE POINT WHERE I NEED GLASSES FOR BOTH DISTANT AND NEAR VISION. WE HAVE TRIED EVERY TYPE OF THERAPY FOR THE DRY EYE WITH NO SUCCESS. BEFORE THE SURGERY I TOLD DR THAT MY EYES WERE TOO DRY FOR ME TO WEAR CONTACT LENSES. HE PERFORMED A TEAR TEST AND TOLD ME THAT ALTHOUGH MY EYES WERE ON THE DRY SIDE OF NORMAL, I WAS A GOOD CANDIDATE. THAT HAS PROVED NOT TO BE THE CASE. IN MY OPINION, IF EYES ARE TOO DRY FOR CONTACT LENS WEAR, THAT SHOULD BE A SERIOUS WARNING SIGN THAT THERE MAY BE DRY EYE PROBLEMS AFTER LASIK. IF I HAD TO DO IT OVER AGAIN I WOULD NOT DO LASIK. A RECENT TEAR TEST PERFORMED BY DR SHOWS THAT THE TEAR PRODUCTION IN THE RIGHT EYE IS UNCHANGED FROM PRIOR TO SURGERY, BUT TEAR PRODUCTION IN THE LEFT EYE IS LESS THAN HALF WHAT IT WAS PRIOR TO SURGERY. IN ADDITION, ALTHOUGH IT'S A MINOR PROBLEM, AT NIGHT I NO LONGER HAVE THE VERY SHARP VISION HAD WITH GLASSES. STARS DO NOT APPEAR AS SINGLE DOTS OF LIGHT, BUT HAVE A SLIGHT STAR-BURST APPEARANCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NA LASIK LZS NA NA

Patients

Seq Age Sex Outcome Treatment
1 46 YR Other