BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1916575 · Received December 1, 2010

    Report

    Report Number
    1119421-2010-01324
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ALCON LABORATORIES IRELAND LTD
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS UNHAPPY WITH HER OUTCOME. THE SURGEON REPORTED THE PT WAS LEFT WITH 1.5 DIOPTER CYLINDER WITH A SPHERICAL LENS AND SPHERICAL CORNEAL KERATOMETRY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD SN60AT 20915255

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other