BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1944369 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01282
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    October 22, 2010
    Report Date
    December 17, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY SURGERY). (B)(4) (LOW). (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.0 MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO LOW 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 CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK