BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1822048 · Received August 24, 2010

    Report

    Report Number
    2023826-2010-00832
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 19, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 IN PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B)(6)2010 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT HAD NARROWING OF THE ANGLE. 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 FOAM TIP PLUNGER: MODEL - LOT NUMEBR - UNK| CARTRIDG: MODEL - SFC-45 FP, LOT NUMBER - UNK| INJECTOR: MODEL - MSI-PF, LOT NUMBER - UNK