BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY IOL

    MDR report key: 22379246 · Received July 1, 2025

    Report

    Report Number
    3012236936-2025-000182
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 1, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    5050474693005
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. IT WAS INDICATED THAT "OBVIOUSLY VISION ON THE FIRST DAY WAS A BIT CLOUDY. BUT BY DAYS 2 AND 3 ((B)(6) 2025), IT WAS CLEAR THAT THE ARTIFACTS AND LOSS OF CONTRAST WERE WAY MORE SEVERE THAN EXPECTED." SECTION D4: MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IT WAS INDICATED THAT THE LENS WAS A TECNIS ODYSSEY (TORIC) INTRAOCULAR LENS (IOL). SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IT WAS INDICATED THAT THE LENS WAS A TECNIS ODYSSEY (TORIC) IOL. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH SEVERE MYOPIA AND ASTIGMATISM UNDERWENT CATARACT SURGERY DURING WHICH A TECNIS ODYSSEY (TORIC) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THEIR RIGHT EYE. THE PATIENT EXPERIENCED SIGNIFICANT POST-SURGICAL VISION QUALITY ISSUES, INCLUDING LOSS OF CONTRAST AND DETAIL IN DAYTIME DISTANCE VISION, GHOSTING WHILE READING, AND SEVERE NIGHTTIME HALOING. IT WAS INDICATED THAT THE PATIENT'S MENTAL HEALTH DECLINED SIGNIFICANTLY DUE TO THE UNEXPECTED OUTCOMES, NECESSITATING PROFESSIONAL MENTAL HEALTHCARE INTERVENTION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER TORIC LENS OF MODEL ZCU300 DUE TO HALOS, GLARE, AND VISUAL DISTURBANCES. AFTER THE LENS EXCHANGE SURGERY, THE PATIENT IMMEDIATELY NOTICED THAT HER VISION QUALITY WAS SUBSTANTIALLY IMPROVED AND WAS BETTER THAN THE PATIENT'S UNOPERATED EYE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327900 TECNIS ODYSSEY IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. UNKNOWN 5050474693005

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention