BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1202142 · Received October 16, 2008

    Report

    Report Number
    2023826-2008-01302
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A SILICONE THREE PIECE LENS AND A PIECE OF THE LENS WAS TORN OFF. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES.

    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. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR INJECTOR: MODEL UNK| CARTRIDGE: MODEL UNK