BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON OPHTHALAS LASER

    MDR report key: 86365 · Received June 21, 1996

    Report

    Report Number
    86365
    Event Type
    Other
    Date Received
    June 21, 1996
    Date of Event
    November 28, 1995
    Report Date
    April 2, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/28/95 PT HAD ONE FOCAL LASER TREATMENT. 11/28/95 L EYE #41 0.1 100 MICRONS 170 M.W 12/27/95 C/O TEARING. 12/29 FLUORESCEIN ANGIOGRAPHY. 1/17/96 DIAGNOSED SUBRETINAL NEOVASCULARIZATION. TREATMENT DONE-ANOTHER CO'S. 3/22/96 FOLLOW-UP SUBRETINAL NEOVASCULARIZATION IS NO LONGER PRESENT. SUMMARY 19 PTS REC'D 31 TREATMENTS OF THESE 19 PTS- 16 HAVE BEEN FOLLOWED-UP-3 HAD COMPLICATIONS OF SUBRETINAL NEOVASCULARIZATION. THREE PTS LOST TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON OPHTHALAS LASER OPHTHALAS LASER HQF ALCON LABORATORIES OPHTHALAS 532 LASER --

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other