BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1941818 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01431
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 WAS REQUESTED ON 11/29/2010 AND 12/02/2010 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON DOES NOT BLAME THE LENS FOR THE EVENT, BUT IS UNSURE OF THE CAUSE. THE PT HAS A (B)(6) HISTORY OF WEARING RIGID GAS PERMEABLE (RGP) LENSES, WHICH WERE DISCONTINUED THREE MONTHS PRIOR TO THE IMPLANT SURGERY. 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 SN60WF 10967673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other