BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR 58

    MDR report key: 2700697 · Received August 9, 2012

    Report

    Report Number
    MW5026493
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    March 1, 2012
    Report Date
    August 9, 2012
    Manufacturer
    CLEARLAB SG PTE LTD
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT SPECIFICATION INCORRECT. WATER CONTENT CLAIMED BY MFR TO BE 58%. ACTUAL WATER CONTENT IS 54%. CONTACT LENS HAVE NO UV BLOCKING PROPERTIES CONTRARY TO CLAIMS BY MFR. DATES OF USE: (B)(6) 2012. REASON FOR USE: FOR EYESIGHT CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR 58 1-2 WEEK DISPOSABLE SOFT CONTACT LENS LPL CLEARLAB SG PTE LTD CLEAR58 L11104
    2 CLEAR 58 1-2 WEEK DISPOSABLE SOFT CONTACT LENS LPL CLEARLAB SG PTE LTD CLEAR58 J11180

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR