BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 6385275 · Received March 7, 2017

    Report

    Report Number
    3005675890-2017-00018
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    February 7, 2017
    Report Date
    July 10, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    UDI-DI
    05050474604810
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP #1 REPORT THE DATE RECEIVED BY MANUFACTURER WAS INCORRECTLY DOCUMENTED AS 5/5/2017. THE CORRECT DATE THAT THE INFORMATION WAS RECEIVED IS 6/1/2017.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUAL, TRENDING, DEVICE HISTORY RECORDS AND RISK DOCUMENTATION REVIEWS FOR THE DEVICE WAS PERFORMED. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO ISSUES AS ALL UNITS PASSED FINAL ASSEMBLY TESTING. IT SHOULD BE NOTED THAT BOTH LIQUID OPTICS INTERFACES OR LOIS (LOI-14) AND LOI-12 DEVICES USE THE SAME TESTING PROGRAMS AND CRITERIA FOR RESULTS DURING THE LEAK TESTING AND FINAL ASSEMBLY TESTING AND THEREFORE WOULD NOT BE CAUGHT AT EITHER OF THESE TESTING STATIONS. A COMPLAINT HISTORY REVIEW SHOWS THAT THIS IS THE ONLY RECORDED INCIDENT FOR INFORMATION LABELING INVOLVING THIS LOT NUMBER AND THIS PRODUCT FAMILY. BASED ON THIS IT WAS CONCLUDED THAT THE DEVICE HAS A LABELING DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER OPENING THE LIQUID OPTICS INTERFACE (LOI) BOX AND INSIDE TRAY LABELED AS LOI-12 IT WAS FOUND THAT THE LOI INSIDE THE PACKAGE WAS A DIFFERENT PRODUCT SIZE: LOI-14. THIS OCCURRED PRIOR TO START OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166141 LIQUID OPTICS INTERFACE CATALYS LIQUID OPTICS INTERFACE OOE ABBOTT MEDICAL OPTICS LOI-12 1227213 05050474604810

    Patients

    Seq Age Sex Outcome Treatment
    1