BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1240856 · Received November 6, 2008

    Report

    Report Number
    2023826-2008-01369
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 15, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (LENS DID NOT EJECT PROPERLY FROM CARTRIDGE), EVALUATION RESULTS- (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON HAD PARTIALLY INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS BEFORE HE DISCOVERED THE LENS WAS NOT COMING OUT OF THE CARTRIDGE PROPERLY. THE LENS WAS PULLED OUT IMMEDIATELY AND THE BACKUP LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A TECHNICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR FOAM TIP PLUNGER: MODEL FOAM TIP PLUNGER-| INFECTOR: MODEL MSI-PF- LOT NUMBER UNK| LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP- LOT NUMEBR UNK