BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2195103 · Received July 14, 2011

    Report

    Report Number
    9612169-2011-00029
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT TIME. FINAL COMMENTS: COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND CAPA WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. BASED ON OUR CURRENT TRENDS, 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 (B)(6) 2011. THE SURGEON'S CONTACT INFO WAS NOT PROVIDED; F/U COULD NOT BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED A FOCUSING PROBLEM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER REPORTED "I STAND TWO METERS AWAY FROM THE CALENDER WHICH HAS BOLDFACE FIGURES ONE CENTIMETER HIGH, GOOD AND BLACK. WHEN I FOCUS COVERING THE RIGHT EYE I SEE THE NUMBER I HAVE SELECTED PRACTICALLY CLEAR, THE NUMBER ABOVE AND BELOW ARE NOT CLEAR; BACKING AWAY FROM THE CALENDER I SEE LESS AND LESS." THE SURGEON'S CONTACT INFO WAS NOT PROVIDED; F/U COULD NOT BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21020335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other