BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1936663 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01456
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2005
    Report Date
    November 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; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE ARTICLE DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO FURTHER INFO IS EXPECTED. IWASE T. TANAKA N. REITERATIVE MEMBRANOUS PROLIFERATION WITH GIANT-CELL DEPOSITS ON HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES AFTER TRIPLE PROCEDURES IN EYES WITH CATARACTS AND UVEITIS. CUTANEOUS AND OCULAR TOXICOLOGY 2010; 29:306-311. (B)(4).

    Description of Event or Problem · 1

    IN AN ARTICLE, A SURGEON REPORTED TWO PTS (THREE EYES) WITH REITERATIVE MEMBRANOUS PROLIFERATION WITH GIANT-CELL DEPOSITS ON THE INTRAOCULAR LENSES (IOL) FOLLOWING IOL IMPLANT SURGERY WITH VITRECTOMY, IN EYES WITH UVEITIS AND VITREOUS OPACITY. IN THE ARTICLE, IT WAS REPORTED THAT THE PT'S BCVA HAD IMPROVED TO 20/25 IN THE LEFT EYE. AQUEOUS AND VITREOUS FLARE WAS STRONG DURING THE FIRST POSTOPERATIVE WEEK, BUT THE INTRAOCULAR INFLAMMATION GRADUALLY DECREASED. BY NINE MONTHS AFTER SURGERY, THE POSTERIOR CAPSULE OPACIFICATION (PCO) WITH GIANT-CELL DEPOSITS HAD BECOME OBVIOUS, WITH A DECREASE OF BCVA. A YAG LASER WAS PERFORMED. HOWEVER, RECURRENT MEMBRANOUS PROLIFERATION WITH GIANT-CELL DEPOSITS ON THE POSTERIOR SURFACE OF THE IOL WAS DETECTED ONE MONTH AFTER THE TREATMENT. REPEATED MONTHLY LASER MEMBRANOTOMY (FIVE TIMES IN TOTAL) WAS REQUIRED TO OBTAIN A COMPLETE BLOCK OF REITERATIVE MEMBRANOUS PROLIFERATION. TWENTY MONTHS FOLLOWING THE LAST LASER MEMBRANOTOMY, THE FINAL BCVA WAS 20/15. NO FURTHER INFO IS EXPECTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GENTAMYCIN| TRIAMCINOLONE| BETAMETHASONE| SUTURES| IRRIGATION/ASPIRATION (I/A) TIP