BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1120024 · Received August 14, 2008

    Report

    Report Number
    2023826-2008-01062
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 23, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE LENS WAS RECEIVED SPLIT IN HALF WITH A CLEAR SURGICAL RESIDUE ON IT. CONCLUSION: OFF LABEL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED AN AQ2015A THREE PIECE SILICONE LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. CUSTOMER WAS AWARE THAT THE CARTRIDGE USED IS NOT THE ONE RECOMMENDED FOR THIS LENS.

    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 COMPANY AQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL: CQ CARTRIDGE FP| INJECTOR MODEL MSI-PM