BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1200081 · Received October 15, 2008

    Report

    Report Number
    2023826-2008-01291
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 19, 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

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE RELATED TO THE SURGEON'S LOADING TECHNIQUE. IT SHOULD BE NOTED THAT THE INJECTOR, CARTRIDGE AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS INSERTING A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS, BUT THE LENS WOULD NOT EJECT FROM THE CARTRIDGE. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE LENS NOT EJECTING FROM THE CARTRIDGE MAY HAVE BEEN DUE TO THE SURGEON'S LOADING TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INJECTOR: MODEL MSI-PF| LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL FOAM TIP PLUNGER| CARTRIDGE: MODEL SFC-45 FP