BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 3934274 · Received June 27, 2014

    Report

    Report Number
    1644019-2014-00113
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.65 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHILE USING A KNIFE FROM A CUSTOM PAK DURING A PROCEDURE ON A PATIENT WITH ADVANCED GLAUCOMA, HE FOUND THE KNIFE BLUNT. THE SURGEON OBSERVED THE BLADE DIFFICULT TO INITIALLY INSERT BUT WHEN IT FINALLY WENT THROUGH, IT WENT IN TOO FAST AND RUPTURED THE PATIENT'S CAPSULAR BAG. THE SURGEON ALSO REPORTED THAT HE MANAGED TO INSERT A LENS BUT THE SHAPE OF THE KNIFE WAS LEFT IMPRINTED ON THE CAPSULAR BAG. AT THE MOMENT OF THIS REPORT HE DID NOT KNOW WHAT FURTHER DAMAGE HAD OCCURRED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377343 CUSTOM PAK COVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CLEARCUT KNIFE (DATE UNKNOWN)| UNKNOWN IOL (UNKNOWN DATE)