BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1242557 · Received November 21, 2008

    Report

    Report Number
    2023826-2008-01415
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 4, 2008
    Report Date
    November 3, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN 2008. THE LENS WAS EXPLANTED ON APPROX A MONTH LATER, DUE TO INADEQUATE VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER| INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK