BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1241163 · Received November 20, 2008

    Report

    Report Number
    2023826-2008-01402
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 31, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (IRIDECTOMY).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON IMPLANTED A 12.5 MM ICM125V4 IMPLANTABLE COLLAMER LENS IN 2008. THE LENS WAS EXPLANTED THREE MONTHS LATER, DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT EXPERIENCED NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. AN IRIDECTOMY WAS PERFORMED. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention CARTRDIGE: MODEL| FOAM TIP PLUNGER: MODEL| INJECTOR: MODEL