BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3010260 · Received March 12, 2013

    Report

    Report Number
    1119421-2013-00269
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 12, 2013
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED UNEXPECTED OUTCOMES IN THREE PTS. TWO PTS HAD BILATERAL UNEXPECTED OUTCOMES, FOR A TOTAL OF FIVE EYES. THIS REPORT IS FOR THE RIGHT EYE OF THE THIRD PT, WHO IS BILATERALLY IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104327 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AD1 12048659

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other