BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATARACT PACK

    MDR report key: 449537 · Received March 19, 2003

    Report

    Report Number
    1423395-2003-00001
    Event Type
    Other
    Date Received
    March 19, 2003
    Date of Event
    January 22, 2003
    Report Date
    March 19, 2003
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY WHILE PERFORMING A LEFT CATARACT EXTRACTION, DR. INJECTED VISCO-ELASTIC THROUGH SURGICAL SPECIALTIES CORPORATION'S PRODUCT 3107 IN FINISHED GOODS LOT M133680. AFTER INJECTION OF THE VISCO-ELASTIC, REFRACTIVE PARTICLES APPEARED IN THE PATIENT'S LEFT EYE. SOME OF THE PARTICLES WERE IRRIGATED FROM THE PATIENT'S EYE AND SOME PARTICLES REMAINED IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATARACT PACK CONVENIENCE KIT WITH CAPSULE POLISHER LRO MEDLINE INDUSTRIES, INC. DYNJK0215C *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention