BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17546903 · Received August 14, 2023

    Report

    Report Number
    3012236936-2023-02055
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 20, 2023
    Report Date
    October 3, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731721
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: RETURNED TO MANUFACTURER ON:18 AUGUST 2023 SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT DEVICE WAS RECEIVED WITH THE PLUNGER ROD ADVANCED TO THE NECK OF THE CARTRIDGE. THE HANDPIECE ASSEMBLY WAS INSPECTED AND PRESENTED WITH NO ISSUES. THE COMPLAINT CARTRIDGE WAS RECEIVED WITH A DAMAGED CARTRIDGE TIP. THE COMPLAINT LENS WAS RECEIVED CUT IN HALF WITH ONE HALF MISSING. A PIECE OF THE HAPTIC WAS OBSERVED TO BE DETACHED. THE REMAINING HAPTIC WAS MEASURED AND WAS WITHIN SPECIFICATION. THE COMPLAINT ISSUE OF HAPTIC DETACHED WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER ISSUES OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN REVIEWING THE INITIAL MDR, IT WAS NOTICED THAT THE FOLLOWING INFORMATION WAS INADVERTENTLY NOT INCLUDED. THE SURGEON COMPLAINED THAT THE EVENT WAS NOT THE BEST EXPERIENCE OVERALL. THEREFORE, THIS SUPPLEMENTAL REPORT EXPLAINS MEDICAL DEVICE PROBLEM CODE 3191. SECTION H10: MEDICAL DEVICE PROBLEM CODE: 3191 DISSATISFACTION - QUALITY/DESIGN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION E1 TELEPHONE NUMBER : (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, THE ACCOUNT DID NOT PROVIDE THE INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC BROKE IN THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO COMPLICATIONS OF BAG RUPTURE OR CORNEA INJURY AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665399 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 Male