FDA Adverse Event Injury Summary report: N

LASIK

MDR report key: 3202328 · Received June 26, 2013

Report

Report Number
MW5030724
Event Type
Injury
Date Received
June 26, 2013
Date of Event
June 7, 2012
Report Date
June 26, 2013
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD LASIK SURGERY AT (B)(6), THAT THE SURGEON SAID WAS SUCCESSFUL. WHEN I RETURNED THE NEXT DAY FOR FOLLOW-UP, I WAS TOLD EVERYTHING WENT WELL. A WEEK LATER AT A SUBSEQUENT FOLLOW-UP, I COMPLAINED THAT I COULD NOT SEE OUT OF MY LEFT EYE. THE NURSE, (B)(6), SAID TO ME THAT THE VISION WAS PROBABLY OVERCORRECTED, AND I WOULD NEED SURGERY AGAIN. WHEN THE DOCTOR CAME IN, SHE SAID THERE WAS NO OVERCORRECTION; I JUST NEEDED TIME TO HEAL. A MONTH LATER, I COMPLAINED ABOUT THE SAME PROBLEM, AND WAS TOLD AGAIN THAT I JUST NEEDED TO HEAL. I WAS CHARGED (B)(6) FOR TEMPORARY GLASSES TO USE UNTIL MY EYE HEALED. TWO MONTHS LATER, AT THE NEXT FOLLOW-UP, I SAID AGAIN THAT VISION WAS BLURRY OUT OF MY LEFT EYE, BUT AGAIN I WAS TOLD THAT THE SURGERY WAS SUCCESSFUL AND THAT I JUST TOOK LONGER TO HEAL THAN NORMAL. I WAS SCHEDULED FOR ANOTHER FOLLOW-UP 6 MONTHS LATER. I BEGAN TO EXPERIENCE STARBURST, HALOS, DOUBLE-VISION, BLURRED VISION, AND SEVERE HEADACHES. I MADE AN APPOINTMENT WITH AN OPHTHALMOLOGIST ON (B)(6) 2013, WHO ADVISED THAT BECAUSE THE CORRECTED VISION WAS SO DIFFERENT IN EACH EYE -1 IN THE RIGHT, -4.75 IN THE LEFT, I WOULD NEED GLASSES AGAIN TO ALLEVIATE THE SYMPTOMS AND TO SEE CLEARLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
289461 LASIK LZS

Patients

Seq Age Sex Outcome Treatment
1 38 YR Other| R| S