BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1821635 · Received August 25, 2010

    Report

    Report Number
    1119421-2010-00929
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "60 PERCENT OF SIGHT" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "SCRATCH" (SCRATCHED MATERIAL [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED NOTING A SCRATCH ON AN INTRAOCULAR LENS (IOL) FOLLOWING IMPLANTATION. THE SURGEON REPORTED, THE PT HAD 60 PERCENT OF HER SIGHT AT AN EXAMINATION ON THE SECOND POSTOPERATIVE DAY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 20807900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other