BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943519 · Received December 2, 2010

    Report

    Report Number
    1119421-2010-01348
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 25, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL IMPLANT SURGERIES, THE PT REPORTED THAT WITHIN A FEW DAYS AFTER THE SURGERY FOR THE SECOND EYE (LEFT EYE), SHE NOTICED HER VISION FOR BOTH EYES IS "DETERIORATING" AND THE TWO EYES INTERFERE WITH EACH OTHER. THE PT ALSO REPORTED EXPERIENCING DIZZINESS. IN A F/U, THE SURGEON REPORTED THAT THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other