BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2130223 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00715
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    May 11, 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
    OR, 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: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT 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 ON 05/16/2011 AND 05/17/2011 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED IN FOLLOW UP PHONE CALLS ON 05/17/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A SURGEON EXCHANGED BILATERAL INTRAOCULAR LENSES (IOL) DUE TO THE PATIENT BEING UNHAPPY. IN A FOLLOW UP PHONE CALL WITH THE TECHNICIAN, SHE REPORTED THE PATIENT WAS REFERRED TO A DIFFERENT SURGEON FOR A SECOND OPINION DUE TO THE PATIENT EXPERIENCING GLARE DURING THE DAYTIME AND NIGHTTIME. THIS SURGEON EXCHANGED BOTH LENSES FOR THE PATIENT. IN A FOLLOW UP PHONE CALL WITH THE PATIENT, SHE CONFIRMED THAT SHE WAS SEEING CAR HEADLIGHTS AS SUNBURSTS DURING THE DAY AND AT NIGHT. SHE REQUESTED THE LENSES TO BE REMOVED. THE PATIENT CONFIRMED THAT THE GLARE ISSUES RESOLVED FOLLOWING THE EXCHANGE PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 10933523

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention