BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23192095 · Received October 1, 2025

    Report

    Report Number
    3012236936-2025-000254
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 4, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION?: YES. DATE RETURNED TO MANUFACTURER: OCT 13, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE LENS WAS RECEIVED CUT IN HALF, COATED IN VISCOELASTIC RESIDUE AND LINT FROM THE GAUZE, AND WITH THE PIECES STUCK TOGETHER. THE LENS HALVES WERE UNSTUCK AND CLEANED REVEALING THAT THE LENS WAS DAMAGED. 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. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. 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. SECTION H6: HEALTH EFFECT - CLINICAL CODE 4559 (UNSPECIFIED TISSUE INJURY) IS TO CAPTURE THE REPORTED EYELID LUMP. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF BLURRED VISION, INCLUDING DIFFICULTY WITH NEAR VISION. AT THE POST-OPERATIVE VISIT ON (B)(6) 2025, THE PATIENT WAS EXPERIENCING OTHER SYMPTOMS IN THE LEFT EYE, INCLUDING, A "FISHBOWL-LIKE" QUALITY TO PERIPHERAL VISION, THREE WHITE LINES ACROSS CENTRAL VISION AT ALL TIMES, A FOREIGN BODY SENSATION (BUT NO PAIN), A DROOPING UPPER EYELID AND A LUMP. THE PATIENT NOTED IMPROVEMENT IN LIGHT, BUT DENIED IMPROVEMENT IN COLOR. ADDITIONALLY, THE PATIENT MUST ¿BOBBLE¿ THE HEAD TO EXPERIENCE CLEAR VISION. WHEN LOOKING DOWN AT THE LAP, THE PATIENT IS UNABLE TO SEE ANYTHING WITH THE LEFT EYE. VISUAL ACUITY WAS MEASURED AT 20/25-2 WITH A MANIFEST REFRACTION OF -50 +50 ACCESS 160 +3 ADD. THE PATIENT HAS A HISTORY OF TRAUMA FROM A STICK TO THE LEFT EYE. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS (22.5 DIOPTER). THE PROCEDURE DID NOT REQUIRE A VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS NOT REQUIRED. AT THE ONE-WEEK POSTOPERATIVE VISIT ON (B)(6) 2025, THE PATIENT¿S VISUAL ACUITY WAS RECORDED AS 20/50, 20/50 PINHOLE, WITH A MANIFEST REFRACTION OF 20/25, AND NO PAIN WAS REPORTED. IT IS NOTED THAT THE STATUS OF PATIENT WAS IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105806 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZKB00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention PLATINUM CARTRIDGE