BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1709332 · Received June 2, 2010

    Report

    Report Number
    1119421-2010-00647
    Event Type
    Other
    Date Received
    June 2, 2010
    Report Date
    May 3, 2010
    Manufacturer
    ALCON MANUFACTURING, 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
    IN
    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 #. NO ADD'L INFO IS EXPECTED. BHATTACHARJEE, H., BHATTACHARJEE, K., AND BHATTACHARJEE, P. (2007, NOV-DEC). "DELAYED ACCUMULATION OF LENS MATERIAL BEHIND THE FOLDABLE INTRAOCULAR LENS." INDIAN JOURNAL OF OPHTHALMOLOGY 55, 472-475. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "DIMNESS OF VISION" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "WHITISH FLUFFY MATERIAL" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]). A JOURNAL ARTICLE REPORTS TWO CASES OF DELAYED ACCUMULATION OF REGENERATED CORTICAL LENS MATERIAL IN THE CAPSULAR BAGS BEHIND THE INTRAOCULAR LENS (IOL) WITH TRANSIENT IMPAIRED VISION SEVERAL YEARS AFTER IMPLANTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE SECOND PT. FOR THIS PT, THE POSTOPERATIVE PERIOD FOLLOWING BILATERAL IMPLANT SURGERY WAS UNREMARKABLE AND BCVA IN BOTH EYES WAS 20/20. SEVEN YRS AFTERWARD, HE REPORTED A HISTORY OF SUDDEN DIMNESS OF VISION IN THE LEFT EYE, WHICH LASTED A PERIOD OF A FEW MONTHS FOLLOWED BY SPONTANEOUS RECOVERY. THE PT'S BCVA IN THE AFFECTED EYE WAS 20/20. EXAM BY SLIT-LAMP REVEALED A QUIET EYE WITH NORMAL INTRAOCULAR PRESSURE. AFTER MYDRIASIS, SLIT-LAMP EXAM SHOWED A WHITISH FLUFFY MATERIAL INFERIORLY, TRAPPED BETWEEN THE IOL AND THE POSTERIOR CAPSULE. IT WAS DIAGNOSED AS ACCUMULATION OF REGENERATED LENS MATERIAL WHICH DISLODGED FROM THE SUPERIOR FORNIX OF THE CAPSULAR BAG. BECAUSE THERE WAS NO VISUAL IMPAIRMENT, THE PT REFUSED ANY INTERVENTION. THE PT CONTINUED TO BE MONITORED REGULARLY AND THE LAST CHECKUP SHOWED TOTAL ABSORPTION OF THE LENS MATTER. THE POSTERIOR CAPSULE WAS MAINTAINING CLARITY AND WAS NOTED TO BE SEPARATED FROM THE POSTERIOR SURFACE OF THE IOL. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD./HUNTINGTON MA30BA 516960

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other