FDA Adverse Event Injury Summary report: N

NA

MDR report key: 2450190 · Received February 8, 2012

Report

Report Number
MW5024206
Event Type
Injury
Date Received
February 8, 2012
Date of Event
February 15, 2007
Report Date
February 8, 2012
Manufacturer
NA
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

TO WHOM IT MAY CONCERN: DR. (B)(6) PERFORMED LASIK ON BOTH OF MY EYES IN (B)(6) 2007 AT (B)(6). I HAD INITIAL PROBLEMS WITH DOUBLE IMAGES IN THE RIGHT EYE BUT THOSE FADED AWAY AND I HAD 20/20 BOTH EYES WITH THE NEED FOR READING GLASSES. OVER THE COURSE OF THE NEXT YEAR AND A HALF THE VISION IN MY RIGHT EYE CHANGED SO THAT I NO LONGER NEEDED READING GLASSES AND THE VISION GREW SOFT FOR DISTANCE. THE LEFT EYE REMAINED AS IT WAS FOLLOWING THE SURGERY. I NOW HAVE MULTIPLE IMAGES (6) IN MY RIGHT EYE MOST NOTICEABLE WHEN LOOKING AT LIGHTS. WHEN I LOOK AT THE SINGLE LITTLE LED POWER LIGHT ON A TV SET I SEE 6 DISTINCT IMAGES INTERCONNECTED WITH BLURRY LINES. IT BECOMES VERY INTERESTING WHEN DRIVING AT NIGHT OR IN THE RAIN. I LITERALLY HAVE TO CLOSE MY RIGHT EYE. I ATTEMPTED TO CONTACT (B)(6) IN (B)(6) 2010 AND FOUND THAT THEY HAD GONE OUT OF BUSINESS. AFTER A LITTLE SEARCHING, I FOUND THAT DR. (B)(6) WAS NOW WORKING THROUGH (B)(6). I SCHEDULED TO MEET WITH DR. (B)(6) AND AFTER 2 VISITS HE COULD NOT RECOMMEND ANY PROCEDURE THAT MIGHT CORRECT MY CURRENT CONDITION. HE MENTIONED A DOCTOR IN (B)(6) THAT WAS WORKING WITH EQUIPMENT THAT HAD BEEN MODIFIED THAT MIGHT PROVIDE A SOLUTION FOR MY CONDITION BUT BASICALLY STATED I WAS KIND OF STUCK WITH MY CURRENT VISION ISSUE. I WAS ALSO INFORMED THAT SINCE (B)(6) IS NO LONGER IN BUSINESS THAT ANY "WARRANTY" WITH REGARDS TO THE INITIAL PROCEDURE IS NO LONGER VALID. THE VISION IN MY LEFT EYE IS FINE FOR DISTANCE BUT STILL NEEDS CORRECTION TO READ WHICH IS WHAT I EXPECTED BEFORE THE SURGERY. I SOUGHT A SECOND OPINION FROM (B)(6) AND AFTER A COUPLE OF VISITS WE DECIDED TO TRY A SINGLE CONTACT IN THE RIGHT EYE TO SEE IF THAT MIGHT HELP. I ENDED UP WITH A STRONG IN-FOCUS IMAGE WITH SEVERAL SHADOW IMAGES. WHEN TRYING TO READ WITH THE CONTACT IN USING READING GLASSES I GET A 3D MOVIE TYPE IMAGE WITH THE TEXT APPEARING TO STAND OFF THE PAGE. IT IS BEYOND DISTRACTING. (B)(6).

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 45 YR Required Intervention