BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1903073 · Received November 12, 2010

    Report

    Report Number
    2023826-2010-01137
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (WRONG LENS IMPLANTED), (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE IN ERROR. THE SURGEON IMPLANTED LENS MEANT FOR THE RIGHT EYE IN THE LEFT EYE. NO FURTHER INFO AVAILABLE. SEE MFR #2023826-2010-01138 FOR THE OTHER EYE.

    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 FOAM TIP PLUNGER: MODEL UNK, LOT # UNK| CARTRIDGE: MODEL UNK, LOT # UNK| INJECTOR: MODEL UNK, LOT # UNK