BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 384164 · Received March 18, 2002

    Report

    Report Number
    MW1024457
    Event Type
    Malfunction
    Date Received
    March 18, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 18, 2002
    Manufacturer
    ALCON LABS
    Product Code
    HOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATARACT SURGERY AT AMBULATORY SURGERY CTR. AFTER SURGERY, PT WAS GIVEN STANDARD POST-OPERATIVE KIT CONTAINING PROTECTIVE EYEGLASSES, LUBRICATING DROPS, AN EYE SHIELD, TRANSPORE TAPE AND A BOTTLE OF ECONOPRED. AT THE ONE-DAY POST-OP APPOINTMENT WITH SURGEON, PT STATED THEY DIDN'T KNOW WHICH DROPS TO PUT IN THEIR EYE. THE DR LOOKED IN THEIR POST-OP KIT AND FOUND A VIAL OF SUPER GLUE TAPED TO THE BOX OF LUBRICATING TEARS. THE PT HAD NOT USED ANYTHING IN THE KIT AND WAS NOT HARMED, BUT THE POTENTIAL FOR EYE DAMAGE WAS GREAT. THE POST-OP KITS ARE PROVIDED TO SURGERY CTR BY ALCON LABORATORIES, INC. THEY ARE SHIPPED IN CLOSED CARDBOARD BOXES. CONTAMINATION COULD HAVE OCCURRED EITHER AT ALCON, AT THE SURGERY CTR, AT THE PT'S HOME, AT THE DR'S OFFICE OR AT SOME OTHER LOCATION WHERE THE PT WENT BETWEEN THEIR SURGERY AND POST-OP VISIT. RPTR IS REPORTING BECAUSE OF THE POSSIBILITY THAT THE SUPER GLUE MAY HAVE BEEN PUT INTO THE KIT AT ALCON LABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * POST-OP KIT/CATARACT SURGERY HOY ALCON LABS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other