FDA Adverse Event Injury Summary report: N

VISX

MDR report key: 1193647 · Received October 8, 2008

Report

Report Number
MW5008592
Event Type
Injury
Date Received
October 8, 2008
Date of Event
October 23, 1997
Report Date
October 8, 2008
Manufacturer
VISX
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 1997, I HAD LASIK SURGERY PERFORMED ON BOTH EYES. I HAD AN ENHANCEMENT IN 2005, 1998 ON MY RIGHT EYE. I NOW SUFFER FROM DEBILITATING STARBURSTS, HALOS, POOR CONTRAST AND DEPTH PERCEPTION, AND SEVERELY LIMITED LOW LIGHT VISION. WHERE I ONCE WAS ABLE TO DRIVE FREELY AT NIGHT, I CAN NO LONGER GET AROUND EVEN ON FOOT. EVEN IN DAYLIGHT I OFTEN MIX UP MY OWN CHILDREN WITH OTHER PEOPLE'S CHILDREN FROM DISTANCES AS SHORT AS 6 FEET AWAY. I ALSO SUFFER SEVERE HEADACHES FROM INTENSE EYE STRAIN AND THE USE OF PILOCARPINE DROPS -.5%-. PRE-EXISTING CONDITIONS WERE: CONGENITAL NYSTAGMUS, MYOPIA, ASTIGMATISM, NIGHT BLINDNESS - ABLE TO DRIVE AT NIGHT. MY PRE-OPERATIVE READINGS WERE: MEASUREMENT OD OS OU VCC 20/20020/40020/200 BSCVA 20/40 - 20/50, 20/10020/40 - 20/50. REFRACTION. -10.00, -5.75 X 010, 20/80, -10.50, -6.00 X 155. 20/200, 20/75. MY CURRENT VISUAL ACUITY IS AROUND 20/60 - 20/70 OU. ALTHOUGH I VISITED DR'S OFFICE NUMEROUS TIMES TO SEEK HELP WITH THE SYMPTOMS MENTIONED ABOVE, I WAS ALWAYS TOLD THAT EVERYTHING WAS PERFECT AND THAT THESE "SIDE EFFECTS" WERE TEMPORARY AND WOULD GO AWAY, WHICH THEY NEVER DID. IN 2001, I FINALLY GAVE UP ON DR AND SAW ANOTHER LASIK PRACTITIONER WHO INFORMED ME THAT I HAD DECENTERED ABLATIONS, DUE TO MY NYSTAGMUS AND THAT I WAS CONTRAINDICATED FOR LASIK AT THAT TIME. I LATER LEARNED THAT I ALSO HAD SIGNIFICANT HIGHER ORDER ABERRATIONS AND WAS ALSO CONTRAINDICATED, DUE TO THE DEGREE OF MY MYOPIA AND MY PUPIL SIZE. DATES OF USE: 1997 AND 1998. DIAGNOSIS OF REASON FOR USE: IMPROVE VISION TO 20/40 OU, ELIMINATE NEED FOR GLASSES OR CONTACT LENSES. EVENT ABATED AFTER USE STOPPED OR REDUCED: NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VISX VISX STAR EXCIMER LASER LZS VISX B

Patients

Seq Age Sex Outcome Treatment
1 32 YR Required Intervention