BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SVS APEX PLUS

    MDR report key: 162718 · Received April 16, 1998

    Report

    Report Number
    1287364-1998-00002
    Event Type
    Injury
    Date Received
    April 16, 1998
    Date of Event
    March 11, 1998
    Report Date
    April 15, 1998
    Manufacturer
    SUMMIT TECHNOLOGY INC.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BILATERAL LASIK TREATMENT ON 3/11/1998. AFTER THE TREATMENT OF THE PT'S RIGHT EYE THE MICROSCOPE ASSEMBLY ON THE APEX PLUS EXCIMER LASER WAS JARRED. THE TREATMENT OF THE PT'S LEFT EYE RESULTED IN A PARTIAL ABLATION OF THE CORNEA. INFO RECEIVED INDICATED THAT THE PT'S 1 DAY POST-OP UCVA WAS 20/20 RIGHT EYE 20/25 LEFT EYE WITH DIPLOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVS APEX PLUS OPHTHALMIC LASER HQF SUMMIT TECHNOLOGY INC. UV 325000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other