BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1930670 · Received December 8, 2010

    Report

    Report Number
    2023826-2010-01249
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REPAIR IRIS, (B)(4) - STITCH PERIPHERAL IRIDECTOMY, (B)(4): EVALUATION METHOD RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PER MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT REPAIR OF THE IRIS FROM TOO LARGE. PIS WERE DONE TO TREAT PATIENT'S DISTORTED VISION. THIS ADVERSE EVENT WAS CAUSED BY PERIPHERAL IRIDOTOMIES/IRIDECTOMIES THAT WERE TOO BIG, AND NOT BY THE ICL ITSELF. AFTER REPAIR, PT'S SYMPTOMS WERE RESOLVED. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, THE EVENT WAS CAUSED BY PERIPHERAL IRIDOTOMIES/IRIDECTOMIES THAT WERE TOO BIG, AND NOT BY THE ICL ITSELF.

    Description of Event or Problem · 1

    THE PT REPORTED THE SURGEON IMPLANTED A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS IN HER RIGHT EYE (OD) ON (B)(6) 2006. THE PT REPORTED HAVING TWO SURGERIES TO REPAIR THE IRIS AND STITCH UP ONE PERIPHERAL IRIDECTOMY BECAUSE OF DISTORTED VISION. THE PT'S PROGNOSIS IS EXCELLENT AND THE POST-OP BCVA WAS 20/40. THE ICL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL 12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention CARTRIDGE: MODEL AND LOT # UNK| FOAM TIP PLUNGER: MODEL AND LOT # UNK | INJECTOR: MODEL AND LOT # UNK| CARTRIDGE: MODEL AND LOT # UNK| FOAM TIP PLUNGER: MODEL AND LOT # UNK| INJECTOR: MODEL AND LOT # UNK