BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1941850 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01460
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 3, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 12/06/2010 BY PHONE. THE NAME OF THE IMPLANTING SURGEON IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTS HER VISION HAS DETERIORATED FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. SHE REPORTED THAT THE LENSES WERE SET, SO SHE WOULD SEE 20/20 WITHOUT GLASSES AND THAT THEY WERE PERFECT FOR ABOUT SIX YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 771220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other