BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2099500 · Received April 12, 2011

    Report

    Report Number
    1119421-2011-00569
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. 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. ADDITIONAL INFORMATION WAS REQUESTED 04/13/2011, 04/14/2011, 04/28/2011 AND 05/09/2011 BY FAX, MAIL AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED 04/13/2011 AND 05/09/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED 04/28/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT IS EXPERIENCING GLARE AND IS UNABLE TO READ IN DIM LIGHT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A FOLLOW UP, THE SURGEON REPORTS THE EVENT CONTINUES, BUT WILL RESOLVE WITH TREATMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11058148

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other AMO HANDPIECE| ARTIFICIAL TEARS| GLASSES