FDA Adverse Event Malfunction Summary report: N

AMO COMPLETE MOISTURE PLUS

MDR report key: 859781 · Received May 29, 2007

Report

Report Number
MW5002290
Event Type
Malfunction
Date Received
May 29, 2007
Date of Event
November 1, 2006
Report Date
May 29, 2007
Manufacturer
AMO
Product Code
LPN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE ABOVE DATE IS APPROXIMATE. ACCORDING TO AN FDA PRESS RELEASE RECEIVED IN MY E-MAIL ADVANCED MEDICAL OPTICS VOLUNTARILY RECALLS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION. IN 2006, I EXPERIENCED WHAT MAY HAVE BEEN THE INFECTION CITED AS ACANTHAMOEBA KERATITIS. I HAD THE SYMPTOMS BUT THOUGHT THAT IT WAS CAUSED WHEN I TOOK MY CONTACTS OUT AND PINCHED MY EYE ACCIDENTALLY. I CALLED MY EYE DOCTOR, DR. APPROXIMATELY ONE TO TWO WEEKS LATER AS THE PAIN AND IRRITATION WERE BECOMING UNBEARABLE. I COULD NOT WEAR MY CONTACTS ANYMORE. HE RECOMMENDED A SYSTANE FREE LIQUID GEL EYE LUBRICANT DROP. I USED THIS FOR THE NEXT 3 WEEKS AND FINALLY CLEARED UP THE INFECTION. TO THIS DAY I CAN NOT WEAR MY CONTACTS WITHOUT IRRITATION-NEW ONES INCLUDED AND CHALKED IT UP TO BEING SOMEONE THAT JUST CAN'T GET ALONG WITH CONTACTS. I'VE ALSO NOTICED THAT MY VISION IS NOT AS GOOD WITH MY GLASSES. I GOT MY PRESCRIPTION IN 2006, SO I FIGURED I'D JUST DEAL WITH IT UNTIL MY NEXT VISIT WITH MY EYE DOCTOR. NOW THAT I KNOW ABOUT THIS RECALL I HAVE TO WONDER IF IN FACT THIS IS THE REASON FOR MY DILEMMA. YES, THE AMO RECALL SOLUTION IS THE ONE THAT I USE. WHOM DO I CONTACT ABOUT A SOLUTION TO MY PROBLEM? SINCERELY, DATES OF USE: 2006- 2007. DIAGNOSIS: STORAGE AND CLEANING OF CONTACT LENS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMO COMPLETE MOISTURE PLUS NONE LPN AMO AB00101
2 MULTI PURPOSE SOLUTION NONE LPN AMO AB01610

Patients

Seq Age Sex Outcome Treatment
1 YR