BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1416641 · Received January 28, 2009

    Report

    Report Number
    2023826-2009-00086
    Event Type
    Other
    Date Received
    January 28, 2009
    Date of Event
    November 13, 2008
    Report Date
    December 30, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH PIECES TORN OFF AND MISSING. BOTH HAPTICS WERE TORN OFF. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015 COLLAMER THREE PIECE LENS AND THE TRAILING HAPTIC TORE OFF. THE LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE LENS DAMAGE WAS DUE TO A LOADING ERROR.

    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. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT NUMBER UNK| INJECTOR MODEL MSI-TM - LOT NUMBER UNK