BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-OK OPHTHALMIC KNIVES

    MDR report key: 8753548 · Received July 2, 2019

    Report

    Report Number
    2523835-2019-00291
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Report Date
    October 2, 2019
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF A DULL BLADE THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD RELATED TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION FOR DEVICE COMPONENT LOTS TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THERE ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE COMPONENT LOTS FOR THE REPORTED ISSUE. A PHOTO ATTACHED TO THE PARENT COMPLAINT WAS REVIEWED BY THE MANUFACTURING SITE. THE PHOTO IS A PHOTOCOPY OF THREE TYVEKS THAT CONFIRM THE REPORTED PRODUCT AND LOT INFORMATION FOR THIS FILE AND QS (B)(4). A SAMPLE WAS NOT RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO ACCEPTANCE CRITERIA THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE THIRD OF THREE COMPLAINTS FROM THIS REPORTER. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT MULTIPLE KNIFE BLADES WERE NOTED TO BE DULL DURING SEPARATE CATARACT SURGERIES. EACH PROCEDURE WAS COMPLETED WITH THE UNSATISFACTORY KNIFE WHICH REQUIRED ADDITIONAL PRESSURE IN ORDER TO MAKE THE INCISION. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO IMPACT TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550111 A-OK OPHTHALMIC KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 256518M

    Patients

    Seq Age Sex Outcome Treatment
    1