BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON LABORATORIES, INC

    MDR report key: 530606 · Received June 17, 2004

    Report

    Report Number
    530606
    Event Type
    Malfunction
    Date Received
    June 17, 2004
    Date of Event
    March 10, 2004
    Report Date
    June 16, 2004
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A PT WHO UNDERWENT A PHACOEMULISIFICATION OF CATARACT; PLACEMENT OF INTRA-OCULAR LENS TO LEFT EYE AND ANTERIOR VITRECTOMY LT EYE. DURING INTRAOCULAR LENS MA6OAC WAS FOLDED AND PLACED IN THE SULCUS. HOWEVER UPON INITIAL INSERTION INTO THE EYE, IT WAS NOTED THAT THE LEADING HAPTIC WAS BROKEN OR KINKED APPROX 1MM FROM ITS INSERTION ONTO THE OPTIC. THE BREAK WAS SIGNIFICANT ENOUGH TO COMPROMISE THE PROPER UNFOLDING OF THE HAPTIC. THE LENS WAS PROPERLY ROTATED OUT OF THE EYE AND ANOTHER MA6OAC LENS WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES, INC INTRAOCULAR LENS HQL ALCON LABORATORIES MA60AC 21.5D *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR