BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1063756 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00848
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 23, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A TORIC SINGLE PIECE SILICONE LENS MODEL AA4203TL AND THE LENS TORE AND A PORTION BECAME STUCK IN THE CARTRIDGE AND A PORTION WENT INTO THE EYE. THE SURGEON REMOVED IT WITHOUT ENLARGING THE INCISION AND REPLACED IT WITH ANOTHER SAME MODEL LENS. NO PT INJURY. THE INJECTION SYSTEM THEY USED IS NOT RECOMMENDED IN THE LABELING FOR THIS TYPE OF LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INJECTOR MODEL: INDIGO-P LOT# UNK| FOAM TIP PLUNGER: FTP-INDIGO LOT# UNK| CARTRIDGE MODE: SFC-25FP LOT# UNK