FDA Adverse Event Injury Summary report: N

AMO

MDR report key: 860956 · Received June 1, 2007

Report

Report Number
MW5002375
Event Type
Injury
Date Received
June 1, 2007
Date of Event
May 30, 2007
Report Date
June 1, 2007
Manufacturer
AMO
Product Code
LPN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
UT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE BEEN USING THE AMO COMPLETE MOISTURE PLUS MULTI-PURPOSE SOLUTION FOR CLEANING AND STORING MY CONTACTS. I PURCHASED MY AMO PRODUCT IN A FOREIGN COUNTRY AND IT IS DEFINITELY THE AMO PRODUCT FROM THE STATES. LAST SATURDAY, I NOTICED A STING IN MY LEFT EYE AND THOUGHT IT WAS ALLERGIES, AND LEFT IT ALONE. ON SUNDAY MORNING WHEN I WOKE UP, I COULD NOT OPEN MY EYE, THE PAIN WAS SO INTENSE THAT I COULD NOT BEAR IT. I KEPT ON SUNGLASSES AND SUFFERED THROUGHOUT THE DAY, AND ON MONDAY MORNING, I WOKE UP TO THE MOST EXCRUCIATING PAIN I HAVE EVER HAD IN MY EYE, I COULD NOT OPEN THE EYE AT ALL, IT WAS SWOLLEN SHUT AND IT FELT LIKE THERE WAS SAND IN MY EYE, I COULD NOT DO ANYTHING TO ALLEVIATE THE PAIN, I TOOK ASPIRIN, PURCHASED EYE WASH AND NOTHING HELPED WITH THE PAIN I HAD. IT WAS IMPOSSIBLE TO SEE, AND I DID NOT PUT MY CONTACT BACK IN MY LEFT EYE, BUT THE IRRITATION BECAME WORSE AND WORSE AS THE DAY WENT BY, I HAD TO HAVE SOMEONE ELSE DRIVE ME. TUESDAY MORNING, THE PAIN WAS STILL THERE, BUT IT HAD RESIDED A BIT AND DUE TO A HEAVY WORK LOAD, I WORKED A FULL 10 HR DAY WITH DOUBLE SUNGLASSES ON. I WENT HOME ON TUESDAY NIGHT AND THE PAIN STARTED WHEN I LAID DOWN TO SLEEP, ON WEDNESDAY MORNING, THE EYE WOULD OPEN, AND I CAN SEE SOMEWHAT, BUT THE SORENESS AND THE RED EYE IS UNBEARABLE FOR MOST TO LOOK AT. LAST NIGHT I SAW THE SPECIAL ON KSL 5 NEWS ABOUT THE COMPLETE MOISTURE PLUS SOLUTION, I RAN INTO MY BATHROOM TO CHECK THE BRAND THAT I WAS USING AND SURE ENOUGH, IT IS THE BRAND. THE STRANGE PART ABOUT THIS WHOLE DEAL IS I PURCHASED THIS SOLUTION IN A FOREIGN COUNTRY AND IT STATES IT IS MADE IN THE USA! SO BE CAREFUL OF SOLUTION YOU HAVE. I DO NOT WANT TO GO TO JUST ANY CLINIC FOR EYE WASH OR ANTIBIOTICS, I WANT A SPECIALIST WHO MAY KNOW ABOUT THIS INFECTION AND CAN TREAT IT RIGHT THE FIRST TIME, ANY IDEAS ARE VERY WELCOME TO ASSIST ME IN THIS PROBLEM. I HOPE SOMEONE CAN ADD SOME LIGHT ON WHAT WE CAN DO WITH THIS PROBLEM AND ASSIST OTHERS IN CORRECT PROCEDURES FOR HELP, AS TO NOT LOSE VISION OR CREATE PERMANENT EYE DAMAGE. TO DATE I HAVE BEEN TO THREE DRS AND AM NOW UNDER CARE OF A CORNEA TRANSPLANT SURGEON WHICH IS CONDUCTING COMPLETE TESTING OF MY CONTACT AND THE CLEANER FOR A SOLUTION TO ASSIST ME IN KEEPING MY EYESIGHT. I CONTACTED THE CO AND THEY CLAIM THAT THIS IS A VOLUNTARY RECALL BUT THERE IS NOT A PROBLEM WITH THEIR PRODUCT. PLEASE DON'T LET THIS HAPPEN TO OTHERS, IT IS NOT WORTH THE RISK. DOSE: EYE SOLUTION. FREQUENCY: DAILY. DATES OF USE: TWO MONTHS IN 2007. DIAGNOSIS OR REASON FOR USE: CONTACT SOLUTION AND RINSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMO LENS CLEANING SOLUTION LPN AMO COMPLETE MOISTURE AB03210

Patients

Seq Age Sex Outcome Treatment
1 48 YR Other| R| S