BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY IOL

    MDR report key: 23998729 · Received January 7, 2026

    Report

    Report Number
    3012236936-2026-000012
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 10, 2025
    Report Date
    February 27, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED, HOWEVER PHOTOS WERE PROVIDED. THE CUSTOMER PROVIDED PHOTOS WERE EVALUATED. THE PHOTOS DISPLAY A MARKED-UP IMAGE OF THE SUSPECT LENS. A CRACK-LIKE MARK NEAR A LENS HAPTIC WAS OBSERVED. DUE TO NO PRODUCT BEING RECEIVED, NO FURTHER EVALUATION COULD BE PERFORMED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D4, MODEL AND CATALOG NUMBER: UNKNOWN/NO INFORMATION. SECTION D4, SERIAL NUMBER: UNKNOWN/NO INFORMATION. SECTION D4 EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 UNIQUE IDENTIFIER (UDI) NUMBER: A PARTIAL UDI WAS PROVIDED AS THE SERIAL NUMBER IS NOT AVAILABLE. SECTION D6A IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B IF EXPLANT; GIVE DATE: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4, DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT 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 DURING SURGERY OF THE JOHNSON AND JOHNSON (JNJ) ODYSSEY INTRAOCULAR LENS (IOL) THE DOCTOR NOTICED MARKS RESEMBLING A GASH ON THE OPTIC. THE SURGEON NOTED THAT THIS ISSUE OCCURS FREQUENTLY, APPROXIMATELY ONCE EVERY TWO WEEKS, WITH THE MARK TYPICALLY APPEARING ON THE MID PERIPHERY OF THE IOL, TANGENTIAL TO THE RINGS, AND VARYING IN SIZE. THE MARK IS PRESENT WHEN THE LENS COMES OUT OF THE INJECTOR AND IS ALWAYS IN THE SAME LOCATION. THE IOL REMAINS IMPLANTED. HOWEVER, ADDITIONALLY, ON THE DAY OF THE EVENT, TWO LENSES WITH CENTRAL GOUGES WERE IMPLANTED AND SUBSEQUENTLY EXPLANTED. NO PATIENT HARM WAS REPORTED. THE ADDITIONAL EXPLANTED IOLS ARE REPORTED IN THE FOLLOWING MANUFACTURER REPORT NUMBERS 3012236936-2025-0003414 AND 3012236936-2025-0003415.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51187 TECNIS ODYSSEY IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown