BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023587 · Received January 13, 2011

    Report

    Report Number
    9612169-2011-00001
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 17, 2010
    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
    IS
    Reporter Occupation
    UNKNOWN

    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 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 SIMILAR COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. FINAL COMMENTS: COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING GLARE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTED THE PATIENT WAS EXPERIENCING TWO TYPES OF GLARE. THE FIRST TYPE WAS RAYS EXTENDING FROM A LIGHT SOURCE LIKE AN OILY GLASS THAT HAD BEEN WIPED WITH A CLOTH. THE OTHER TYPE WAS RANDOM LIGHT SPOT/LINES SCATTERED AROUND A LIGHT SOURCE. THE SECOND TYPE OF GLARE WAS PARTICULARLY BAD AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21001611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MONARCH DELIVERY SYSTEM