BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 7574013 · Received June 6, 2018

    Report

    Report Number
    1119421-2018-00712
    Event Type
    Injury
    Date Received
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: A RARE DISEASE NOWADAYS - UVEITIS-GLAUCOMA-HYPHEMA (UGH) SYNDROME - A CASE REPORT. PER THE REPORT UGH SYNDROME IS TRIGGERED BY FRICTION CAUSED BY THE MECHANICAL CONTACT OF PARTS OF THE ARTIFICIAL LENS WITH THE IRIS. THE COMPANY LENS WAS REPORT TO BE IMPLANTED INTO THE SULCUS. PER THE DIRECTIONS FOR USE (DFU): COMPANY POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INTENDED TO BE POSITIONED IN THE POSTERIOR CHAMBER OF THE EYE, REPLACING THE NATURAL CRYSTALLINE LENS. THIS POSITION ALLOWS THE LENS TO FUNCTION AS A REFRACTIVE MEDIUM IN THE CORRECTION OF APHAKIC. THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG. (B)(4)

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REPORTED THAT AFTER HAVING AN INTRAOCULAR LENS (IOL) IMPLANTED, A PATIENT EXPERIENCED VITREOUS / ANTERIOR CHAMBER HEMORRHAGE AND UVEITIS GLAUCOMA HYPHEMA (UGH) SYNDROME FOR THE PAST 13 YEARS. HIS CURRENT INTRAOCULAR LENS (IOL) IS DECENTERED. KRALL E, REITSAMER H. A NOWADAYS RARE DISEASE - THE UVEITIS-GLAUCOMA-HYPHEMA (UGH) SYNDROME - A CASE REPORT. SPRINGER. BAND 32/HEFT 2, 2018 (98) ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417276 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON MA50BM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other