BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATIC CORNEAL SHAPER

    MDR report key: 330234 · Received May 1, 2001

    Report

    Report Number
    6000108-2001-00001
    Event Type
    Injury
    Date Received
    May 1, 2001
    Date of Event
    March 16, 1999
    Report Date
    April 6, 2001
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY COUNSEL FOR THE OPHTHALMOLOGY FELLOW: IN 1999, AN OPHTHALMOLOGY FELLOW AND THE ATTENDING PHYSICIAN, PERFORMED A REFRACTIVE SURGERY ON PT'S LEFT EYE. PROCEDURE WAS ABORTED DUE TO A PARTIAL BUTTONHOLE. CILOXAN, FLAREX AND ACULAR DROPS WERE ADMINISTERED. A BANDAGE CONTACT LENS WAS PLACED ON THE OPERATED EYE. THE BANDAGE CONTACT LENS WAS REMOVED ON 2ND DAY. POST-OP EXAMINATIONS WERE DONE SUBSEQUENTLY SEVERAL TIMES IN 1999, AND ALSO IN 2000. PTK THERAPY WAS RECOMMENDED BUT THE PT REJECTED IT. PT REMAINS WITH A VISUAL DEFECT. REFRACTIVE SURGERY ON PT'S RIGHT EYE WAS UNEVENTFUL. PRE-OP BCVA: 20/20 OD & 20/15-1 OS POST OP: UNCORRECTED VISION WAS 20/20 OD & BCVA 20/35 OS.

    Description of Event or Problem · 1

    INFO WAS RECEIVED 2001 THAT A PT HAD A REFRACTIVE SURGERY IN 1999. IT WAS FURTHER STATED THE PT HAD AN UNSPECIFIED "IRREVERSIBLE" INJURY IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19999 AUTOMATIC CORNEAL SHAPER KERATOME, AC-POWERED HNO BAUSCH & LOMB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other