BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11697314 · Received April 20, 2021

    Report

    Report Number
    2648035-2021-07613
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    September 22, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655454
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE IMPACT CODE 2199- NO HEALTH CONSEQUENCES OR IMPACT PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. IMPACT CODE 2199 IS NO LONGER APPLICABLE. THE CORRECT IMPACT CODE IS 4631-REMOVAL AND REPLACEMENT. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT - IMPACT CODE: 4631 REMOVAL AND REPLACEMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRELOADED UNIT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY : UNKNOWN/ NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAS BEEN INSERTED PREMATURELY IN THE PATIENT EYE DURING THE PROCESS THE LENS CAME OUT FROM THE EYE AND LENS WAS REMOVED AND REPLACE DURING THE SAME PROCEDURE, NO PATIENT INJURY WAS REPORTED. CUSTOMER DOES NOT WANT TO BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589770 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown