BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1241161 · Received November 20, 2008

    Report

    Report Number
    2023826-2008-01413
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 31, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (IRIS DAMAGE), (LENS DAMAGED). EVALUATION RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND SMALL SCRATCHES ON ONE HAPTIC. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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 INSERTED A 12.6 MM MICL 12.6 IMPLANTABLE COLLAMER LENS AND THE LENS WAS DAMAGED. THE LENS WAS REMOVED, AND THE PATIENT HAD IRIS DAMAGE AND HYPHEMA. THE BACKUP LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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 35 YR Required Intervention INJECTOR: MODEL| CARTRIDGE: MODEL| FOAM TIP PLUNGER: MODEL