BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1822061 · Received August 24, 2010

    Report

    Report Number
    2023826-2010-00827
    Event Type
    Injury
    Date Received
    August 24, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS. SURGERY IS PENDING TO EXPLANT LENS DUE TO REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED. FURTHER INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL WILL BE SUBMITTED WHEN FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM125V4 NA

    Patients

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