BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 22367698 · Received June 30, 2025

    Report

    Report Number
    3012236936-2025-000167
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 5, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474726123
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER PROVIDED A PHOTO THAT WAS EVALUATED. THE PHOTO DISPLAYED THE SUSPECT CARTRIDGE AND HANDPIECE. THE CARTRIDGE TIP WAS OBSERVED TO BE DEFORMED. THEREFORE, DUE TO NO PRODUCT RECEIVED, NO FURTHER EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUES "LENS DAMAGED", "OVERRIDE", AND "PLUNGER ROD ISSUE" WERE NOT IDENTIFIED DURING PHOTO EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOUND TO BE DAMAGED IN A DEFORMED CARTRIDGE. THE LENS HAD BEEN INSERTED, BUT THE PATIENT IS CURRENTLY AWAITING A REPLACEMENT. THROUGH FOLLOW-UP, WE LEARNED THAT ONE DAY POST-OPERATIVE EVERYTHING WAS FINE. THE IOL DAMAGE IS IN THE PERIPHERAL PART OF THE OPTICAL ZONE. THE PUPIL WAS NARROWED, SO THE OPTICAL QUALITY WAS GOOD SO FAR. LENS EXPLANT IS A POSSIBILITY IF DURING THE NEXT FOLLOW-UP VISIT A VISIBLE DEFECT IS CONFIRMED IN THE OPTICAL PART AFTER THE PUPIL HAS DILATED. REGARDING THE INJECTOR, THERE WERE CRACKS AND DEFORMATION IN THE PLASTIC END OF THE ROD THAT PUSHES THE IOL FORWARD. THE LENS GOT STUCK TO THE BOTTOM AND THE INJECTOR MOVED FORWARD OVER IT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430683 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474726123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown