BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1101889 · Received August 7, 2008

    Report

    Report Number
    2023826-2008-01043
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN 2008. THE LENS WAS EXPLANTED TWO DAYS LATER, DUE TO EXCESSIVE VAULTING. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. THE REPORTER STATED THE CAUSE OF THE EXCESSIVE VAULTING WAS DUE TO A SIZING ISSUE. THE PT HAD A MICL 13.2 IMPLANTED IN THE OTHER EYE AND THAT LENS WAS ALSO REMOVED - SEE MFR REPORT # 2023826-2008-01044. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

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