BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2116693 · Received May 20, 2011

    Report

    Report Number
    1119421-2011-00624
    Event Type
    Other
    Date Received
    May 20, 2011
    Date of Event
    March 1, 2009
    Report Date
    April 22, 2011
    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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED, THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 04/25/2011, 04/26/2011 AND 05/05/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS FOCUS RANGE WAS ABOUT 24 TO 50 INCHES. HE STATED, HIS LENS WORKS WELL, BUT HE WOULD LIKE TO SEE DISTANCE. THE CONSUMER REPORTED, HE WANTED TO BE ABLE TO SEE THE TELEVISION WITHOUT WEARING GLASSES. HE SITS APPROX 100 INCHES FROM HIS TELEVISION. THE CONSUMER REPORTED THAT HIS LEFT EYE WAS SUPPOSED TO BE CORRECTED FOR DISTANCE, BUT HE SEES WELL UP CLOSE. ADD'L 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 10842723

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other