BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1081258 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00993
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 8, 2008
    Report Date
    July 2, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS IN 2008. AT A POST-OPERATIVE VISIT, IT WAS DISCOVERED THAT THE TP HAD ENDOPHTHALMITIS. THE PT'S CURRENT BEST-CORRECTED VISUAL ACUITY IS 20/100- AND THERE IS VITREOUS DEBRIS/HAZE OVER MACULA AND IT IS SLOWLY CLEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL 12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK| LOT NUMBER 1237013| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER