BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22989593 · Received September 7, 2025

    Report

    Report Number
    3012236936-2025-000233
    Event Type
    Injury
    Date Received
    September 7, 2025
    Report Date
    October 28, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810808
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION B3, DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE CUSTOMER INDICATED (B)(6) 2024. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD 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 THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: SEP 30, 2025. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE LENS WAS RECEIVED CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED REVEALING THAT THE LENS WAS SCRATCHED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE IOL WAS EXPLANTED BECAUSE THE PATIENT STATED HE COULD NOT SEE ANYTHING, STILL NEEDED BIFOCALS FOR EVERYTHING, THE NIGHT HALOS WERE VERY BAD, AND THEIR EYES HURT A LOT. THE IOL WAS REPLACED WITH NON- JOHNSON AND JOHNSON MODEL LI61AO +22.5. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. THERE WAS NO CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE CUSTOMER INDICATED THAT THE EXPLANTED PRODUCT HAS ALREADY BEEN RETURNED TO JNJ. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THIS REPORT CAPTURES THE LEFT EYE. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0002331.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333293 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention