FDA Adverse Event Injury Summary report: N

NA

MDR report key: 1842497 · Received September 19, 2010

Report

Report Number
MW5017489
Event Type
Injury
Date Received
September 19, 2010
Date of Event
January 15, 2010
Report Date
September 19, 2010
Manufacturer
NA
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD CUSTOM LASIK SURGERY (B)(6)2010. I WAS HIGH PRESCRIPTION -8.5 NEAR-SIGHTED WITH ASTIGMATISM. PRIOR DRY-EYE ISSUES, BUT NOT EXTREME. VERY ACTIVE. A 15-YEAR VEGETARIAN. SINCE SURGERY, I HAVE NEVER SEEN CLEARLY AGAIN. IT IS SCARY TO DRIVE AT NIGHT SINCE I CANNOT SEE STREET SIGNS OR TURNS UNTIL IT'S TOO LATE TO TURN OR COMPLETELY MISS THE TURN, AND I HAVE ALMOST CAUSED 4 CAR ACCIDENTS. I EXPERIENCE DOUBLE VISION, BLURRY VISION, WEIRD FOCUSING PROBLEMS WITH MOVEMENT OR NEAR-TO-FAR, HEADACHES, AND DRY EYES ALL THE TIME. MY LEFT EYE - I CAN SEE, BUT IT IS INFERIOR TO CONTACTS, ONLY WITH GOOD LIGHT WHEN NOT EXPERIENCING THE OTHER PROBLEMS. MY RIGHT EYE - HAS NEVER BEEN CLEAR. THE RIGHT IS ALWAYS BLURRY NEAR OR FAR AND, I EXPERIENCE MORE PROBLEMS WITH DOUBLE VISION AND DRYNESS ETC. I HAVE GONE BACK SEVERAL TIMES FOR EXAMINATION AS TO MY BLURRINESS, ETC AND AM TOLD THERE IS NOTHING THEY CAN FIND. IT HAS BEEN ALMOST A YEAR NOW WITH NO RESOLUTION. I CONTINUE TO USE EYE DROPS -THEIR SUGGESTION- OFTEN WHICH DO NOT GIVE ANY REAL RELIEF TO THE PROBLEMS I EXPERIENCE AND ADVIL DOESN'T HELP THE HEADACHES AS THEY ARE CAUSED BY WEIRD FOCUSING ISSUES THAT MAKE ME DIZZY AND TIRED. WHEN IN CROWDS OF PEOPLE I FEEL SELF-CONSCIENCE SINCE I CANNOT SEE, ESPECIALLY AT AN EVENING EVENT. WHEN GOING TO (B)(6) OR SHOPPING I CANNOT SEE (B)(6) LABELS UNTIL WALKING DOWN THE AISLE. WHEN I'M TIRED OR MY EYES FEEL DRY, IT'S MUCH WORSE AND CAN LAST FOR A CONSTANT OF SEVERAL DAYS. I HAVE TRIED TAKING MORE VITAMIN A, ZINC, OMEGA 3 AND OMEGA 6, PROTEIN, BUT ALL HAVE NOT SIGNIFICANTLY IMPROVED ANYTHING. OVERALL, I WISH I NEVER HAD THE SURGERY. I HAVE ALL THE PROBLEMS OF CONTACTS, BUT FEEL THAT I WILL NEVER SEE CLEARLY AGAIN FOR THE REST OF MY LIFE.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 35 YR Required Intervention