BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 24206137 · Received January 28, 2026

    Report

    Report Number
    3012236936-2026-000028
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    September 16, 2024
    Report Date
    January 29, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811799
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING SITE, AS IT REMAINS IMPANTED; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, AND THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS PO NUMBER HAVE BEEN RECEIVED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT FOLLOWING THE IMPLANTATION OF A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT AND LEFT EYE, THE PATIENT EXPERIENCED PERSISTENT HALOS AROUND LIGHTS IN BOTH EYES. THE PHYSICIAN HAD INDICATED THAT THE HALOS WOULD RESOLVE WITHIN A MONTH, THEN SIX MONTHS, AND EVENTUALLY OVER TIME; HOWEVER, THE ISSUE HAS PERSISTED FOR 15 MONTHS WITHOUT IMPROVEMENT. THE PATIENT DESCRIBED SEEING ONE OR TWO CIRCLES OF LIGHT AROUND EVERY LIGHT SOURCE, REGARDLESS OF BRIGHTNESS OR TIME OF DAY, WHICH AFFECTS DAILY ACTIVITIES SUCH AS NIGHT DRIVING AND VIEWING LIGHTED DECORATIONS DURING HOLIDAYS. THE HALOS INTERFERE WITH VISIBILITY OF TURN SIGNALS AND SEEING THE BACKS OF VEHICLES AHEAD WHILE DRIVING AT NIGHT AND ARE DISRUPTIVE DURING DAYTIME ACTIVITIES. THE PATIENT ALSO REPORTED SUBOPTIMAL NEAR AND ARM'S LENGTH VISION, OCCASIONALLY REQUIRING READERS FOR TASKS SUCH AS LAPTOP WORK. THE LENSES REMAIN IMPLANTED, AND NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED OR PLANNED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS CAPTURING THE EVENT FOR THE RIGHT EYE. A SEPARATE REPORT WILL CAPTURE THE EVENT FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267795 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474811799

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other