BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1912207 · Received November 18, 2010

    Report

    Report Number
    2023826-2010-01153
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    June 17, 2010
    Report Date
    October 22, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LENS INSERTED UPSIDE-DOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) 12.0MM IMPLANTABLE COLLAMER LENS UPSIDE DOWN. THE LENS WAS TORN BY FORCEPS WHEN IT WAS REMOVED FOR THE ANTERIOR CHAMBER. NO PT INJURY.

    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 20 YR