BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19843179 · Received July 26, 2024

    Report

    Report Number
    3012236936-2024-000202
    Event Type
    Injury
    Date Received
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746718
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION 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 H6: HEALTH EFFECT - CLINICAL CODE: 2140 - VISUAL DISTURBANCES: PHOTOPHOBIA/INCREASED LIGHT SENSITIVITY-TRANSIENT : PHOTOPHOBIA DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, DEVICE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE 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 MONOFOCAL LENS WAS EXPLANTED DUE TO VISUAL ACUITY IMPROVING BUT STILL A LITTLE HAZY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT VISUAL ACUITY IS CLEAR BUT PATIENT CANNOT READ STREET SIGNS OR READ CAPTIONS ON TV. THE PATIENT IS EXPERIENCING ITCHING AND BURNING, PHOTOPHOBIA, OR OIL FILM. THE PATIENT DAILY ACTIVITY WAS SIGNIFICANTLY AFFECTED. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733176 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746718

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention