BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1191568 · Received October 1, 2008

    Report

    Report Number
    2023826-2008-01242
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 4, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCTS SHOWED THAT A HAPTIC WAS TORN OFF AND BENT, AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON A THREE PIECE SILICONE LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER INDICATED THE INCIDENT WAS DUE TO A LOADING ERROR.

    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 82 YR STAARVISC II| INJECTOR: MODEL UNK| CARTRIDGE: MODEL AQ CARTRIDGE -FP