FDA Adverse Event Injury Summary report: N

ADVANCED MEDICAL OPTICS, INC.

MDR report key: 874955 · Received January 27, 2007

Report

Report Number
MW5002888
Event Type
Injury
Date Received
January 27, 2007
Date of Event
May 25, 2007
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 JUNE 27, 2007. AFTER USING COMPLETE MOISTURE PLUS CONTACT LENS SOLUTION, WHICH WAS PURCHASED AT STORE. 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, I CALLED INTO WORK AT HOSPITAL WITH EYE REDNESS AND SORENESS WITH SENSITIVITY TO THE SUN. I WAS DIAGNOSED AS PINK EYE. BY 3 AM, THE NEXT DAY, THE PAIN, SWELLING AND REDNESS WAS SO SEVERE, I EXPERIENCED PAIN LIKE NO OTHER I HAVE EVER KNOWN. THE SAME DAY, I WAS TAKEN AS AN EMERGENCY IN A DR. OFFICE AN OPHTHALMOLOGIST HERE ON STATEN ISLAND. 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 HAS DIMINISHED MY CORNEA AREA 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: INTRACORNEA. DATES OF USE: TWO WEEKS IN 2007. DIAGNOSIS: CONTACT LENS USE. EVENT ABATED AFTER USE STOPPED: NO. EVENT REAPPEARED: NO.

Devices

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

Patients

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