BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23753075 · Received December 8, 2025

    Report

    Report Number
    3012236936-2025-000323
    Event Type
    Injury
    Date Received
    December 8, 2025
    Report Date
    January 7, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474748361
    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. SECTION D9: DATE RETURNED TO MANUFACTURER: DEC 11, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED, AND NO ISSUES WERE OBSERVED. NO FURTHER EVALUATION WAS PERFORMED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED 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 B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. THE BEST ESTIMATE DATE IS BETWEEN JUN 9, 2025 AND OCT 6, 2025. 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 WERE 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 EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO "WRONG POWER". IT IS UNKNOWN IF THE PATIENT HAD A LOSS OF 2 OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIU375 21.0 DIOPTER). THERE WAS NO PATIENT INJURY. NO UNPLANNED SURGICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. THERE ARE NO PLANNED SURGICAL INTERVENTIONS. THE PATIENT¿S OUTCOME INITIALLY REPORTED AS FINE; HOWEVER LATER IT WAS INDICATED TO BE UNKNOWN AND IT IS UNKNOWN IF THE REPLACEMENT LENS IMPROVED OR RESOLVED THE PATIENT'S SYMPTOMS. THERE IS NO INFORMATION AVAILABLE REGARDING WHETHER THE INCORRECT LENS POWER WAS DUE TO A CALCULATION ERROR OR A USE ERROR. IT WAS CONFIRMED THAT THE LENS DID NOT MALFUNCTION, ITS POWER MATCHED THE INTENDED SPECIFICATION, AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113786 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU375 05050474748361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention