BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11558708 · Received March 23, 2021

    Report

    Report Number
    2648035-2021-07429
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 19, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636057
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION AND ADDITIONAL INFORMATION: SECTION B5: ADDITIONAL: SUBSEQUENT FOLLOW UP INFORMATION RECEIVED FROM THE SURGERY CENTER CONFIRMS THAT THERE WAS NO MISFIRE AND IT WAS AN USE ERROR THAT THE PLUNGER WAS ADVANCED TOO FAR BY USER. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. SECTION H6: ADDITIONAL: MEDICAL DEVICE PROBLEM CODE: 2920 - DIFFICULT TO ADVANCE SECTION H6: ADDITIONAL: MEDICAL DEVICE PROBLEM CODE: 1670 - USE OF DEVICE PROBLEM UPON REVIEWING THE COMPLAINT FOLDER, IT HAS BEEN DETERMINED THAT THERE WAS NO MISFIRE AND IT WAS AN USE ERROR THAT THE PLUNGER WAS ADVANCED TOO FAR BY USER. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. BASED ON OUR REPORTABLE CRITERIA, THIS REPORT IS NO LONGER A REPORTABLE EVENT. THEREFORE, AN EMDR IS REQUIRED TO STATE THAT NO FURTHER FOLLOW UPS WILL BE SENT OUT UNDER MEDWATCH 2648035-2021-07429. G8: CORRECTION: IN REVIEW OF MEDWATCH 2648035-2021-07429 AND PER NEW INFORMATION RECEIVED, THIS EVENT HAS BEEN ASSESSED NOT REPORTABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DEPLOYED TOO FAR BEFORE INSERTION. THERE WAS PATIENT CONTACT. HOWEVER, THERE WAS NO INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448508 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636057

    Patients

    Seq Age Sex Outcome Treatment
    1