FDA Adverse Event Injury Summary report: N

ADVANCED MEDICAL OPTICS, INC

MDR report key: 990657 · Received January 27, 2008

Report

Report Number
MW5005160
Event Type
Injury
Date Received
January 27, 2008
Date of Event
May 25, 2007
Report Date
January 27, 2008
Manufacturer
ADVANCED MEDICAL OPTICS, INC
Product Code
LPN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THIS REPORT IS BEING REPORTED 06/27/07. THE DATE OF PURCHASE, IN 2007, AFTER WHICH I BEGAN TO USE THIS SOLUTION FOR THE FIRST TIME WITHIN A FEW DAYS OF THE PURCHASE. THIRTEEN DAYS LATER, CALLED INTO WORK AT HOSP WITH EYE REDNESS AND SORENESS WITH SENSITIVITY TO THE SUN. I WAS DIAGNOSED AS PINK EYE. BY 3AM, ONE DAY LATER, THE PAIN SWELLING AND REDNESS WAS SO SEVERE I EXPERIENCED PAIN LIKE NO OTHER I HAVE EVER KNOWN. PRIOR TO THAT DAY, I WAS TAKEN AS AN EMERGENCY IN A DR OFFICE AN OPHTHALMOLOGIST. HE DIAGNOSED A BACTERIAL INFECTION. I WAS TREATED WITH ANTIBIOTICS. HE HAS SEEN ME WEEKLY SINCE. THERE IS SCAR TISSUE ON MY CORNEA. I LOST MY EYESIGHT FOR 4 DAYS IN MY RIGHT EYE WITH LITTLE VISIBILITY IN MY LEFT EYE. AFTER MY EYESIGHT RETURNED SLIGHTLY MY COLOR VISION DISAPPEARED FOR A PERIOD OF 4 DAYS ON AND OFF. MY EYESIGHT IS DIMINISHED MY CORNEAS ARE SCARRED AND I HAVE BEEN TOLD THAT IF THIS HAPPENS AGAIN, I AM AT RISK FOR BLINDNESS. PLEASE RESPOND AS SOON AS POSSIBLE. DOSE OR AMOUNT: 20 DROPS, FREQUENCY: TWICE DAILY, ROUTE: INTRACORNEAL. DATES OF USE: FOURTEEN DAYS IN 2007. DIAGNOSIS OR REASON FOR USE: CONTACT LENSE USE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: NO

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ADVANCED MEDICAL OPTICS, INC COMPLETE MOISTURE PLUS PREMIUM EYECARE 12 FL OZ - 355 LPN ADVANCED MEDICAL OPTICS, INC AM50562US10B ZB03732

Patients

Seq Age Sex Outcome Treatment
1 46 YR Other| R| S