BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 135553 · Received December 3, 1997

    Report

    Report Number
    1287364-1997-00001
    Event Type
    Injury
    Date Received
    December 3, 1997
    Date of Event
    June 1, 1997
    Report Date
    November 3, 1997
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THE FOLLOWING: THE REPORTER'S FIRST PROCEDURE WAS A LASIK TREATMENT ON HIS LEFT EYE IN APRIL 1996. THE REPORTER'S VISION WAS STILL POOR, BUT SOMEWHAT IMPROVED. A PRK PROCEDURE WAS DONE ON THE SAME EYE IN JUNE 1996, RESULTING IN LEGAL BLINDNESS FROM CORNEAL SCARRING AND IRREGULAR ASTIGMATISM. THE REPORTER HAS BEEN TOLD THAT THE DAMAGE IS IRREVERSIBLE AND THEIR VISION IS NOT CORRECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK OPHTHALMIC LASER HQF SUMMIT TECHNOLOGY, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other