BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21806893 · Received April 9, 2025

    Report

    Report Number
    3012236936-2025-000088
    Event Type
    Injury
    Date Received
    April 9, 2025
    Report Date
    June 13, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    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

    SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, DEVICE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: APRIL 24, 2025 SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE COMPLAINT LENS WAS RECEIVED CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS HALVES WERE CLEANED REVEALING SCRATCHES. 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 ISSUE. BASED ON THE PRODUCT EVALUATION, THE COMPLAINT ISSUES COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DOCTOR THAT THE LENS WAS EXPLANTED DUE TO BLURRY DISTANCE VISION, TROUBLE DRIVING AT NIGHT AND POOR NIGHT VISION. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN ODYSSEY LENS WITH A POWER OF 20.0 DIOPTER. THERE WERE NO PATIENT INJURIES AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454330 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention