BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22768168 · Received August 10, 2025

    Report

    Report Number
    3012236936-2025-000213
    Event Type
    Injury
    Date Received
    August 10, 2025
    Date of Event
    March 11, 2025
    Report Date
    September 24, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810754
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 8/18/2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES WERE OBSERVED. CONCLUSION: THE COMPLAINT ISSUES WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATION. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING 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, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ODYSSEY INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO NIGHT-TIME DYSPHOTOPSIAS AND POOR INTERMEDIATE VISION. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST-OPERATIVE BCVA WAS 20/20-1. DIRECTIONS FOR USE WERE FOLLOWED. MEDICAL ATTENTION AND MEDICATION OUTSIDE OF STANDARD CARE WERE NOT REQUIRED. NO DEBILITATING CONDITION. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159944 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810754

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention