BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 600DS

    MDR report key: 357158 · Received October 19, 2001

    Report

    Report Number
    2028159-2001-00320
    Event Type
    Injury
    Date Received
    October 19, 2001
    Date of Event
    September 19, 2001
    Report Date
    September 20, 2001
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED RETINAL TEAR OCCURRED DUE TO CUTTING PERFORMANCE OF PROBE. CHANGED PROBES AND COMPLETED CASE. PHOTOCOAGULATION AND AIR EXCHANGE WERE REQUIRED.

    Description of Event or Problem · 1

    PT REPORTED AS RECOVERED, 10/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46967 ACCURUS 600DS OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CTR ACCURUS 600DS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention