BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1091043 · Received August 1, 2008

    Report

    Report Number
    2023826-2008-01024
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    April 22, 2008
    Report Date
    July 8, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN 2007, IN THE PATIENT'S RIGHT EYE (OD). THE LENS WAS EXPLANTED IN 2008, 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 CO. ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL MSI-PF - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| LOT NUMBER UNK