BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TICON 55 UVB

    MDR report key: 579894 · Received March 3, 2005

    Report

    Report Number
    MW1034859
    Event Type
    Injury
    Date Received
    March 3, 2005
    Report Date
    March 3, 2005
    Manufacturer
    ST. SHINE OPTICAL GROUP CO.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TW
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    "THE CONTACT LENS PRODUCED BY MFR ST. SHINE OPTICAL GROUP ARE NOT BEING STERILIZED. THEY PUT "STERIL" "FDA" ON PACKAGE BOX. THEY USE HARD WATER PRODUCING CONTACT LENSES EVERYDAY. IN THE PAST COUPLE YEARS, THE 3 AUTOCLAVE - ARMSCO/H-L THEY USE FOR STERILIZING DO NOT REACH THE 121 DEGREES WHICH DOES NOT CONFORM TO THE ISO 13485 MEDICAL DEVICE STANDARD. THE STERILIZING CYCLE LINE IS NOT A STABLE LINE. THEY DO NOT PERFORM THE VALIDATION AND RE-VALIDATION DURING THE MFG PROCESS WHICH IS BEING REQUIRED BY THE "ESSENTIAL REQUIREMENT". CLEAN ROOM ENVIRONMENT DID NOT REACH THE ACCEPTABLE CRITERIA, THERE IS NO INSPECTION RESULT TO PROVE THEY CONFORM THE STANDARD. THEY HAVE BEEN WARNING BY THE EUR COMMUNITY AUDITOR FOR SEVERAL YEARS. AND TOLD THEM SHOULD STOP PRODUCTION. FOR THE Q.A. DIV, THE LAB SAMPLING ONLY COULPE PIECES CONTACT LENS FORM A 1000000 BASIS SHIPPING OUT LENSES FOR B.I. TEST. THE QA MFG KNOWN THE LENS MAY PUT PT IN A HIGH RISK, BUT HE STILL SIGN PAPER APPROVE SHIPPING. FINALLY, THEY GET RID OFF THE RABBITS THAT THEY USE FOR IRRIATION TEST INAPPROPRIATELY. GET THEM AWAY IN SOME PLACED OR KILLING THEM."

    Description of Event or Problem · 1

    55UVB", IT IS A PRODUCT PRODUCED FOR THE LOCAL MARKET. IT IS NOT SOLD OUTSIDE OF TAIWAN. EVERY CONTACT LENS PRODUCED BY ST. SHINE OPTICAL CO., LTD. UNDERGOES STEAM STERILIZATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TICON 55 UVB CONTACT LENS LPL ST. SHINE OPTICAL GROUP CO. 55UVB PAIYYJ6

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R