BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1833737 · Received September 8, 2010

    Report

    Report Number
    2023826-2010-00886
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 1, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE REPORTER INDICATED, THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE (OD) ON (B)(6)2010. THE LENS WAS EXPLANTED ON (B)(6)2010, DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PT EXPERIENCED NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE ICL 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. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK