BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 731891 · Received June 23, 2006

    Report

    Report Number
    2023826-2006-00856
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# P880091.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4203TF TORIC SILICONE PLATE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME TYPE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INJECTOR MODEL MSI-TR - LOT NUMBER UNK| CARTRIDGE MODEL MTC-60C FP - LOT NUMBER UNK