BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 291059 · Received August 18, 2000

    Report

    Report Number
    2028159-2000-00198
    Event Type
    Injury
    Date Received
    August 18, 2000
    Report Date
    July 21, 2000
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED A SEVERE CORNEAL BURN WHEN HE FINISHED PHACO. WOUND WAS GAPING; SUTURED TO CLOSE. ON FOLLOW-UP PT COMPLAINED ABOUT THE SUTURE, SO IT WAS REMOVED AND WOUND BEGAN LEAKING. PRESSURE PATCH WAS APPLIED OVERNIGHT; THE LEAK STOPPED AND CHAMBER REFORMED. CORNEA IS OPACIFIED 3-4 MM ONTO THE CORNEA WITH CORNEAL STRAIE NOTED. OBSERVED BUBBLES COMING FROM SLEEVE DURING SET UP, AND LEAKING AROUND INCISION DURING PHACO. THOUGHT THE SLEEVE MIGHT HAVE BEEN CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CTR STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention