FDA Adverse Event Injury Summary report: N

NOT APPLICABLE

MDR report key: 1050087 · Received May 20, 2008

Report

Report Number
MW5006974
Event Type
Injury
Date Received
May 20, 2008
Date of Event
April 20, 2001
Report Date
May 20, 2008
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

AFTER CAREFULLY RESEARCHING EXISTING LASIK PROCEDURES AND THE AVAILABLE PROVIDERS, I MADE AN APPOINTMENT FOR THE INITIAL EVALUATION. I HAD WORN GLASSES SINCE THE AGE OF 10, BUT WAS QUITE CAPABLE OF GETTING AROUND WITHOUT THEM--MY EYES WERE NOT THAT BAD! DURING THE EXAM, I WAS REPEATEDLY ASKED IF I HAD A PROBLEM WITH DRY EYES TO WHICH I REPLIED NO. -UNDERSTAND, IF ONE KNOWS NOTHING BUT WHAT IS PRESENT, HOW COULD I KNOW THAT MY TEAR PRODUCTION WAS ABNORMAL? I HAD NEVER BEEN ABLE TO WEAR CONTACTS AND, IN HINDSIGHT, THIS WAS PROBABLY DUE TO LOW TEAR PRODUCTION, BUT, OTHER THAN THIS, I HAD NO INDICATION OF THIS CONDITION. IT WAS NOT AT A POINT THAT IT WAS UNCOMFORTABLE OR DEBILITATING.- I WAS APPROVED FOR THE PROCEDURE WITHOUT RESERVATION. DURING THE PROCEDURE, THE EPITHELIUM OF MY EYE CAME OFF -BOTH EYES-. A CONTACT WAS PUT ON TO HOLD THE TISSUE IN PLACE DURING THE HEALING. I WAS MORE OR LESS "BLIND" FOR THE NEXT 5 DAYS. WHEN REMOVED, THE EPITHELIUM WAS AGAIN LOOSENED AND THE CONTACT HAD TO BE REPLACED. THE HEALING PROCESS WAS LONG AND EXTREMELY UNCOMFORTABLE. FOR THE NEXT MONTH, I WORE SUNGLASSES ALMOST CONSTANTLY AND MY EYES ARE STILL SENSITIVE TO BRIGHT LIGHT. I HAVE HAD 3 CORNEAL EROSIONS SINCE THEN. I MUST PUT A THICK GEL IN MY EYES AT NIGHT TO KEEP THEM FROM DRYING OUT, RESULTING IN ANOTHER CORNEAL EROSION. I HAVE TRIED DROPS, MEDICINE -RESTASIS-, SUPPLEMENTS--ALL OFFER MINIMAL RELIEF. I HAVE PLACED A HUMIDIFIER IN MY HOUSE TO TRY AND FURTHER RELIEVE THE DISCOMFORT. WHILE I DO HAVE 20/20 VISION, I WOULD GLADLY GO BACK TO WEARING GLASSES IN ORDER TO RELIEVE THIS CONDITION!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NOT APPLICABLE LASIK LZS

Patients

Seq Age Sex Outcome Treatment
1 46 YR Required Intervention