BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 851334 · Received May 11, 2007

    Report

    Report Number
    1119421-2007-00201
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 14, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS IN THIS LOT NUMBER. ADD'L INFO WAS REQUESTED 04/18/2007 AND 04/19/2007 BY PHONE, FAX AND MAIL. ADD'L INFO PROVIDED ON 04/19/2007 AND 04/26/2007 BY MAIL.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT HAD A RESIDUAL CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60T5 123944

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other VIGAMOX| NEVANAC| ECONOPRED PLUS 1%| VANCOMYCIN