BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 23782335 · Received December 11, 2025

    Report

    Report Number
    3012236936-2025-000305
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 24, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474726277
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, A PHOTOGRAPH PROVIDED BY THE CUSTOMER WAS EVALUATED. THE PICTURE SHOWED A CRACK/TEAR LIKE MARK LOCATED AT 10:00 IN RELATION TO THE PICTURE AND EXTENDING HORIZONTALLY FOR ABOUT 3-4 MM AND THEN POINTING TO 6:00 FOR ABOUT 5-6 MM. DUE TO THE SIZE AND LOCATION OF THE MARK, IT WOULD BE POSSIBLE FOR IT TO CAUSE POTENTIAL INTRAOCULAR LENS (IOL) INSTABILITY AND/OR VISUAL DISTURBANCES-DISTORTIONS; HOWEVER, THE DEFINITIVE IMPACT TO THE PATIENT AND THE POTENTIAL ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED FROM A PICTURE ASSESSMENT. THE COMPLAINT ISSUE "LENS DAMAGED¿ WAS IDENTIFIED DURING PHOTOGRAPH EVALUATION. HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE EXTENDED DEPTH OF FOCUS TORIC INTRAOCULAR LENS (IOL) IMPLANTATION A TEAR WAS OBSERVED IN THE TRANSITION BETWEEN THE OPTICS AND THE PROXIMAL HAPTIC OF THE IOL. THE SURGEON DECIDED TO PROCEED WITH THE IMPLANTATION AND MONITOR THE SITUATION. THROUGH FOLLOW-UP, WE LEARNED, THAT NO ADDITIONAL MEDICAL INTERVENTIONS WERE PERFORMED OR PLANNED. THE PATIENT IS WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761044 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474726277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown