BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 24157703 · Received January 22, 2026

    Report

    Report Number
    3012236936-2026-000022
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    November 11, 2025
    Report Date
    April 17, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474812000
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: FEB 24, 2026. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. THE LENS WAS VISUALLY INSPECTED AND FOUND TO BE CUT AND HAVE EDGE CHIPS AND WAS COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND RE INSPECTED, AND NO FURTHER ISSUES WERE IDENTIFIED. DURING THE PRODUCT EVALUATION, IT WAS CONFIRMED THAT THE LENS¿S PHYSICAL CHARACTERISTICS MATCHED THOSE OF A DRT-MODEL LENS. 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 A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS 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 ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION WAS REQUIRED. CONCLUSION: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. 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 THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S BOTH LEFT AND RIGHT EYE. THIS REPORT CAPTURES THE LEFT EYE. THE PATIENT EXPERIENCED SEVERE GLARE AND HALOS. THE PATIENT COULD NOT DRIVE OR EVEN LEAVE HER HOME AND WAS DEPRESSED. THE SYMPTOMS PERSISTED WHILE THE LENS WAS IN THE EYE. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, DELAY IN PROCEDURE, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST BSCVA WAS 20/80. CONSEQUENTLY, THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT TYPE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE LEFT EYE. MANUFACTURER REPORT NUMBER. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2026-0000220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515486 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474812000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention