BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1821636 · Received August 25, 2010

    Report

    Report Number
    1119421-2010-00927
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    November 1, 2008
    Report Date
    July 26, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "VA DECREASED, FILMY VISION" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "GLISTENINGS" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT EXPERIENCING DECREASED VISUAL ACUITY SINCE BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE IOL FOR THE RIGHT EYE WAS IMPLANTED APPROXIMATELY 11 YEARS AGO. THE SURGEON REPORTED THAT AFTER LENS INSERTION, VISUAL ACUITY WAS 1.2. (APPROX 20/15). IN 2008, THE PT EXPERIENCED HAZY VISION AND A DECREASE IN VISUAL ACUITY TO 0.5 (20/40). IN 2009, THE SURGEON REPORTED NOTING FURTHER DECREASE IN VISUAL ACUITY TO 0.3 (20/60). THE PT WAS THEN REFERRED TO ANOTHER SURGEON WHO PERFORMED RETINAL EVALUATIONS AND NO PROBLEM WAS OBSERVED. THE SURGEON SURMISED THAT GLISTENINGS COULD BE THE POSSIBLE CAUSE FOR THE DECREASING VISION. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60BM 491910

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other