BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON .2 MM TIP USED WITH ALCON LEGACY 20,000 I/A IRRIGATOR

    MDR report key: 241615 · Received September 22, 1999

    Report

    Report Number
    241615
    Event Type
    Other
    Date Received
    September 22, 1999
    Date of Event
    September 9, 1999
    Report Date
    September 22, 1999
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN 84 YR OLD FEMALE WAS SCHEDULED FOR RIGHT CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT ON 1999. DURING CATARACT EXTRACTION WITH ALCON LEGACY 20,000 THE .2MM I/A (IRRIGATION/ASPIRATION) REUSABLE TIP CAUSED A TEAR IN THE POSTERIOR CAPSULE OF THE RIGHT EYE. THE SURGEON SUCCESSFULLY COMPLETED THE PROCEDURE AND THE PT LEFT THE OPERATING ROOM IN GOOD CONDITION. THE PT WILL BE SEEN FOR SURGICAL POST-OPERATIVE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON .2 MM TIP USED WITH ALCON LEGACY 20,000 I/A IRRIGATOR PHACOEMULSIFICATION MACHINE TIP (ASPIRATION/SUCTION HQE ALCON LABORATORIES ALCON LEGACY 200-0000-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other