BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 875062 · Received July 5, 2007

    Report

    Report Number
    2023826-2007-01152
    Event Type
    Malfunction
    Date Received
    July 5, 2007
    Date of Event
    May 1, 2007
    Report Date
    June 8, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015 COLLAMER THREE PIECE LENS AND THE HAPTIC WAS TORN AS THE LENS WAS BEING INSERTED. THE LENS WAS REMOVED WITH NO REPORTED INJURY. THIS IS ONE OF FOUR LENSES USED FOR THIS PATIENT -SEE MFR REPORT #2023826-2007-01151, 2023826-2007-01153 AND 2023826-2007-01154. A FIFTH LENS WAS IMPLANTED WITH NO PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CA2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CARTRIDGE MODEL CQ CARTRIDGE FP LOT NUMER UNK| VISCOELASTIC MODEL STAARVISC II LOT NUMBER UNK| INJECTOR MODEL MSI-TM LOT NUMBER UNK