BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023647 · Received March 4, 2011

    Report

    Report Number
    9612169-2011-00009
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 4, 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
    IN
    Reporter Occupation
    OTHER

    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 SIMILAR COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. FINAL COMMENTS: THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER (A DOCTOR) REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE IS SEEING RED COLOR IN HIS VISION. IN A F/U, THE CONSUMER FURTHER REPORTED THAT HE BELIEVES THE LIQUID MEDICATION DROPS HE WAS TAKING COULD HAVE CAUSED THIS RED COLORED VISION, AS WHEN HE DISCONTINUED IT, THERE IS AN IMPROVEMENT IN VISION. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND, LTD. SN60WF 21015046

    Patients

    Seq Age Sex Outcome Treatment
    1 Other "LIQUID MEDICATION DROPS"