FDA Adverse Event Injury Summary report: N

EXCIMER LASER

MDR report key: 9098429 · Received September 19, 2019

Report

Report Number
MW5089943
Event Type
Injury
Date Received
September 19, 2019
Date of Event
August 1, 2005
Report Date
September 19, 2019
Manufacturer
UNK
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 1

CALLER CALLED REPORT HAVING PRK LASIK SURGERY AND SOON AFTER SHE HAD VISION LOSS FOR TWO TO THREE DAYS. "I FELT LIKE I WAS GOING BLIND; I HAD BLURRY VISION AND I WAS TERRIFIED". UPON F/U WITH MY DR, HE TOLD ME IT WAS NORMAL PLACED A CONTACT PATCH OVER ONE EYE. THE CONTACT FELT LIKE SAND PAPER, WHEN I QUESTIONED HIM, HE TOLD ME IT WAS NORMAL. THE CONTACT WAS REMOVED FIVE DAYS LATER. MY VISION WAS NORMAL FOR ABOUT A YEAR AND THEN I STARTED TO HAVE INCREASED SENSITIVITY AND HALOS IN MY EYES. IN (B)(6) 2009 I WAS IN A HEAD ON AUTOMOBILE COLLISION AND THE AIR BAGS WERE DEPLOYED. THE CHEMICALS FROM THE AIR BAGS WERE IN MY EYES. I HAD TO WEAR AN EYE PATCH FOR SIX TO EIGHT WEEKS RECOVERY. IN 2011, I STARTED TO HAVE BLURRY VISION AT NIGHT. MY VISION PROGRESSED WORSE AND HAD TO WEAR GLASSES. I WAS TOLD THAT I WOULD HAVE TO WEAR CONTACTS WITH GLASSES. NO ONE WOULD TELL ME WHAT WAS WRONG WITH MY EYES. I REQUESTED MY MEDICAL RECORD. WHEN VISITING THE EYE DR I WAS TOLD THAT I HAVE KERATOCONUS. MY DR NEVER TOLD ME THAT SO, WHEN I ASKED HIM HE SAID THAT I REALLY DON'T HAVE THAT AND THAT HE USES THAT DIAGNOSIS FOR INSURANCE PURPOSES AND MY DIAGNOSIS WAS FOR HIGHER-ORDER ABERRATIONS. I HAVE SERVER CORNEAL SCARRING AND WOULD NEED A CORNEA TRANSPLANT. I POSTED ON INSTAGRAM WHAT WAS HAPPENING TO ME AND SOMEONE MADE COMMENT THAT I COULD HAVE ECTASIA OF THE EYE. I ASKED MY DR ABOUT IT AND HE SAID THAT I COULD HAVE IT AND THE POSSIBILITY WAS IN MY CHART. I BELIEVE THAT I HAVE IT AND ONE WOULD TELL ME WHAT WAS WRONG WITH ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
889672 EXCIMER LASER EXCIMER LASER LZS UNK
889673 ACCESSORIES, SOFT LENS PRODUCTS ACCESSORIES, SOFT LENS PRODUCTS LPL UNK

Patients

Seq Age Sex Outcome Treatment
1 24 YR Other| S