FDA Adverse Event Injury Summary report: N

LASIK

MDR report key: 1693406 · Received May 13, 2010

Report

Report Number
MW5015962
Event Type
Injury
Date Received
May 13, 2010
Date of Event
October 15, 2000
Report Date
May 13, 2010
Manufacturer
NA
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I DON'T REMEMBER THE EXACT DATE OF THE SURGERY, BUT FALL OF 2000 IS ABOUT RIGHT. I HAD LASIK IN BOTH EYES. ONE IS FINE BUT THE OTHER IS NOT. I HAD ASTIGMATISM AND SOMEHOW DURING THE SURGERY, THE LASER ACTUALLY CREATED A 'DIVOT' IN MY CORNEA. THIS HAS CREATED THE EFFECT OF STILL HAVING ASTIGMATISM IN THAT EYE, THOUGH IN THE REVERSE: RATHER THAN A BULGE OR WARPING OUTWARDLY, IT IS A WARPING INWARDLY. A LATER SURGERY WAS PERFORMED ABOUT 5-6 YEARS LATER TO CORRECT THIS BUT IT DID NOT. AS A RESULT, ALONG WITH THE SUDDEN ONSET OF PRESBYOPIA IMMEDIATELY FOLLOWING SURGERY, I'VE NEVER ACTUALLY BEEN COMPLETELY INDEPENDENT OF GLASSES. I ALSO IMMEDIATELY EXPERIENCED THE NEED FOR A VERY BRIGHTLY LIT ENVIRONMENT FOR ME TO SEE WELL ENOUGH AND, AS THE DAY PROGRESSES, I NEED STRONGER AND STRONGER READING GLASSES AND MORE AND MORE LIGHT. AS A RESULT, IT IS DIFFICULT TO CONSIDER A PRESCRIPTION GLASSES REMEDY SINCE, AT ANY GIVEN TIME OF THE DAY, I NEED A DIFFERENT CORRECTIVE STRENGTH. IT HAS CREATED A CROSS-EYED, STRAINED FEELING IF I GO WITHOUT THEM WHEN DOING ANY KIND OF CLOSE TO MID-DISTANCE WORK OR READING. I CAN, HOWEVER, DRIVE OK, ESPECIALLY IF I CLOSE THE ONE EYE. OVER ALL, WHILE I WAS AWARE OF POSSIBLE OVER OR UNDER CORRECTION, I WAS EXPECTING TO BE RID OF THE ASTIGMATISM. WHILE I KNEW THAT PRESBYOPIA COULD BE ACCELERATED, IT WAS NOT EXPLAINED OR EXPECTED THAT IT WOULD BE IMMEDIATE. WHILE THERE IS SOME IMPROVEMENT IN MY FAR DISTANCE, I AM GENERALLY DISAPPOINTED IN THE RESULTS AND HAVE NOT EXPERIENCED THE REASON FOR HAVING LASIK: ELIMINATING OR GREATLY REDUCING THE NEED FOR PRESCRIPTION GLASSES.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 41 YR Required Intervention