BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 23215981 · Received October 3, 2025

    Report

    Report Number
    3012236936-2025-000253
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 4, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. SECTION D9: DATE RETURNED TO MANUFACTURER: OCT 30, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE PLUNGER ROD PARTIALLY ADVANCED WITH VISCOELASTIC RESIDUE OBSERVED THROUGHOUT THE CARTRIDGE. THE CARTRIDGE TIP WAS BENT. NO ISSUES WERE IDENTIFIED WITH THE LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, AND PLUNGER ROD ADVANCEMENT. NO LENS WAS RECEIVED FOR EVALUATION, AND NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE WAS NOT IDENTIFIED DURING PRODUCT EVALUATION AS NO LENS WAS RECEIVED FOR 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 A4: WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5: ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6: RACE: 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 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 THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION 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 PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS DAMAGED WHEN THE LENS PASSED THROUGH THE PRELOADED INSERTER CARTRIDGE. NO RESISTANCE WAS FELT WHILE ADVANCING THE LENS. THE ISSUE WAS NOT RELATED TO USE ERROR. THE LENS WAS IMPLANTED IN THE RIGHT EYE AND THEN HAD TO BE EXPLANTED DURING THE SAME PROCEDURE; CUT AND REMOVED WITHOUT ENLARGING THE INCISION. ANOTHER JOHNSON AND JOHNSON IOL WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED AS REPLACEMENT. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. DUAL VISC VISCOELASTIC (OVD) ACCLIMATIZED TO ROOM TEMPERATURE AND ALCON BALANCE SALT SOLUTION (BSS) WAS USED. THE PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254961 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DUAL VISC OVD AND ALCON BSS