BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS

    MDR report key: 1050124 · Received May 20, 2008

    Report

    Report Number
    MW5007001
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    February 19, 2006
    Report Date
    May 20, 2008
    Manufacturer
    ACUVUE
    Product Code
    LPM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAVE HAD A MAJOR PROBLEM WITH ALL THE SILICON CONTACT LENSES...TRIED FOCUS' NIGHT AND DAY FIRST. AFTER A FEW MONTHS, THE DOCTOR SAID IT WAS LITERALLY CRUSHING MY CORNEA. SWITCHED TO PUREVISION, IT WAS FINE FOR 2 WEEKS, SAME PROBLEM. SWITCHED TO ACUVUE OASYS AND SAME THING. FINE FOR A WEEK OR TWO AND THEN ANY LENS I PUT IN, COULD BE FRESH OUT THE BOX, BURNED MY EYES, THEY WOULD TEAR UP DRAMATICALLY I'D HAVE TO TAKE THEM OUT. THIS IS VERY DISAPPOINTING AS IT FOOLED ME INTO BUYING THE YEAR SUPPLY OF EACH LENS AS THEY ARE FINE AT FIRST, CAUSING ME TO THROW THEM AWAY EACH TIME, I FOLLOW ALL THE DIRECTIONS ON HOW I'M SUPPOSED TO WEAR/CLEAN THEM. I THOUGHT IT WAS JUST ME, BUT HAVE DONE SOME RESEARCH AND THERE ARE THOUSANDS OUT THERE WITH THE SAME PROBLEM. IT MUST BE LOOKED INTO, SOME PEOPLE HAVE SUFFERED MAJOR EYE DAMAGE BECAUSE OF THEM, I'M ONE OF THE LUCKY ONES. THANKS. DOSE OR AMOUNT: 1 YEAR SUPPLY, FREQUENCY: EVERY 2 WEEKS, ROUTE: OPHTHALMIC. DOSE OR AMOUNT: 1 YEAR SUPPLY, FREQUENCY: EVERY 30 DAYS, ROUTE: OPHTHALMIC. DATES OF USE 2006-2008. DIAGNOSIS OR REASON FOR USE: NEEDED TO SEE: NEEDED TO SEE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS OASYS LPM ACUVUE * *
    2 FOCUS NIGHT AND DAY * LPL CIBA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Disability