BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1632752 · Received January 11, 2010

    Report

    Report Number
    2023826-2010-00032
    Event Type
    Other
    Date Received
    January 11, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A MICL12.6MM IMPLANTABLE COLLAMER LENS ON (B) (6) 2009. THE LENS WAS REMOVED DUE TO LENS BEING INSERTED UPSIDE DOWN. THE HAPTIC WAS TORN WHEN LENS WAS REMOVED FROM PT'S EYE. NO WIDEN INCISION AND NO SUTURES REQUIRED. NO PT INJURY. THE REPORTER STATED THE CAUSE OF THIS INCIDENT WAS LOADING ERROR, THE LENS WAS LOADED UPSIDE DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 FOAM TIP PLUNGER: MODEL - LOT # UNK| INJECTOR: MODEL-SFC-PF AND LOT # UNK| CARTRIDGE: MODEL SFC-45 FP AND LOT # UNK