BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 852974 · Received May 11, 2007

    Report

    Report Number
    1119421-2007-00199
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 11, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 04/13/2007, ON 04/17/2007, AND 04/26/2007 BY PHONE, MAIL AND FAX. ADD'L INFO WAS PROVIDED 04/13/2007. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED GLARE AND HALOS. THE LENSES WERE EXPLANTED. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED. RIGHT EYE--OD--MDR #1119421-2007-00198, LEFT EYE --OS--MDR #1119421-2007-00199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 937489

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention