BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 869494 · Received June 21, 2007

    Report

    Report Number
    1119421-2007-00266
    Event Type
    Other
    Date Received
    June 21, 2007
    Date of Event
    April 19, 2007
    Report Date
    May 22, 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
    CT, 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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 05/22/2007, 05/23/207 AND 05/25/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION RECEIVED 05/22/2007, 05/23/2007, 05/25/2007 AND 06/04/2007 BY PHONE AND MAIL.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTS HALOS AT NIGHT AND BLURRY NEAR AND DISTANCE VISION. LEFT EYE MDR #1119421-2007-00265. RIGHT EYE MDR #1119421-2007-00266.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC / HUNTINGTON SN60D3 10604564

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other