BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1063774 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00830
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. A PIECE OF THE LENS OPTIC AND ONE OPTIC HAPTIC WERE TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR, CARTRIDGE AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AND REMOVED A CC4204BF COLLAMER SINGLE PIECE LENS. ADD'L INFO HAS BEEN REQUESTED FROM THE FACILITY, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS IS ONE OF TWO LENSES USED FOR THIS PT - SEE MFR REPORT #2023826-2008-00831.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INJECTOR MODEL AND LOT #UNK| FOAM TIP PLUNGER MODEL AND LOT #UNK| CARTRIDGE MODEL AND LOT#UNK