BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2002611 · Received February 7, 2011

    Report

    Report Number
    2023826-2011-00100
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO PRODUCT MALFUNCTION. RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND HALF OF OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF DARK RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A PATIENT RELATED CONDITION AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS. THE LENS WAS REMOVED DUE TO CAPSULAR BAG WAS TOO WEAK TO HOLD THE LENS. THE SURGEON DECIDED TO IMPLANT AN ANTERIOR CHAMBER LENS INSTEAD. THE INCISION WAS NOT ENLARGED AND NO SUTURES WERE USED. REPORTER STATED THIS EVENT WAS PATIENT RELATED AND NOT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR CARTRIDGE: MODEL- AQ CARTRIDGE-FP, LOT NUMBER: UNK| INJECTOR: MODEL - MSI-TM, LOT NUMBER: UNK