FDA Adverse Event Other Summary report: N

EYEONICS-CRYSTAL LENS

MDR report key: 1050125 · Received May 20, 2008

Report

Report Number
MW5007002
Event Type
Other
Date Received
May 20, 2008
Date of Event
October 27, 2004
Report Date
May 20, 2008
Product Code
HQL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD CRYSTAL LENSES IMPLANTED. I SPENT DOLLARS NOT INCLUDING INSURANCE MONIES CONTRIBUTED. THEY WERE SUPPOSED TO BE 95% SUCCESSFUL. I HAD MANY ADJUSTMENTS WITH LASERS AFTER THE IMPLANTS, WHERE ONE IMPLANT HAS BEEN OPENED UP. THEY SIT ON A HINGE AND SOMETIMES I GET A WEIRD SENSATION IN MY HEAD. I ALSO HAVE TROUBLE WITH COLORS LIKE BLACK, NAVY AND PURPLE THAT I NEVER HAD BEFORE. I STILL HAVE TO WEAR READING GLASSES AND WAS TOLD THAT MY MUSCLES IN MY EYES DO NOT WORK CORRECTLY. THE PROBLEM IS THERE WAS NOT ENOUGH TRAINING FOR THE DOCTOR WHO IMPLANTED THESE AND I WAS ONE OF THEIR FIRST CASES IN THE UNITED STATES. THERE WAS AN OBSERVER IN MY OPERATION ROOM WITH ME FROM CRYSTAL LENS. THEY SHOULD HAVE TRIED CONTACTS OR SOMETHING FIRST TO MAKE SURE I HAD THE RIGHT LENS IMPLANTED AND WHY DO MY EYE MUSCLES NOT WORK. THE DOCTOR ALSO HAD TO BUY SPECIAL EQUIPMENT AFTER I HAD MY SURGERY, SO HE COULD GET A BETTER READ ON THE RIGHT PRESCRIPTIONS. WHY WAS THIS NOT PART OF THE STARTUP COST AND WHY WAS THE PROPER EQUIPMENT NOT IN PLACE BEFORE APPROVING DOCTORS? I ALSO HAVE DAILY HEADACHES SINCE I HAVE HAD THIS SURGERY. I THINK THEIR TOP SURGEON IN THE UNITED STATES SHOULD DO CORRECTED SURGERY ON ME. I WAS TOLD THAT IT WOULD BE A SERIOUS OPERATION TO OPEN UP MY ONE EYE AFTER DR OPENED UP THE LENS. I HAD THIS DONE ON BOTH EYES. THERE WAS NOT ENOUGH TRAINING, DIRECTION FOR THESE LENSES BEFORE HAVING ME AS A GUINEA PIG. I THINK THE COMPANY SHOULD CONTACT ME AND MAKE THIS RIGHT. I HAVE DRY EYE, ALSO. THIS IS A LOT OF MONEY AND I SHOULD HAVE FILED A LAWSUIT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EYEONICS-CRYSTAL LENS CRYSTAL LENS HQL AT-45

Patients

Seq Age Sex Outcome Treatment
1 52 YR Other