BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIEC

    MDR report key: 731880 · Received June 23, 2006

    Report

    Report Number
    2023826-2006-00813
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION CODES RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN WITH A SMALL PIECE MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. A CARTRIDGE WORK ORDER SEARCH WAS PERFORMED AND TWO SIMILAR COMPLAINTS WERE FOUND WITHIN THE LOT OF PRODUCT. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, THE WORK ORDER SEARCHES 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. PMA# P990013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT A CQ2015 COLLAMER THREE-PIECE LENS BUT WHILE THE LENS WAS EJECTING, THE SURGEON NOTICED THE LENS WAS TEARING. THE LENS WAS NICKED AND TORN AT THE OPTIC/HAPTIC JUNCTION. THERE WAS NO PATIENT CONTACT. THIS IS ONE OF TWO LENSES USED ON THIS PATIENT - SEE MFR. REPORT# 2023826-2006-00815.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR INJECTOR MODEL MSI-PM - LOT NUMBER UNK.| CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT # 1212554