BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1944371 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01284
    Event Type
    Injury
    Date Received
    December 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVAL CODES: METHOD - LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN) - BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE PT REPORTED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN HER LEFT EYE (OS) ON (B)(6) 2006. THE PT REPORTED HAVING BEEN PRESCRIBED EYE DROPS FOR AT LEAST THREE CONSECUTIVE MONTHS/OR HAD TO HAVE SURGERY BECAUSE PHYSICIAN STATED PT HAD HIGH PRESSURE OR GLAUCOMA INSIDE THE EYE. 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 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL UNK, LOT#: UNK| CARTRIDGE: MODEL UNK, LOT # : UNK