BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16309862 · Received February 7, 2023

    Report

    Report Number
    3012236936-2023-00267
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    November 28, 2022
    Report Date
    February 6, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474726352
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION AGE, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY INITIAL REPORTER TELEPHONE NUMBER: (B)(6). IT WAS INDICATED THAT THE DEVICE WAS DISCARDED THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS 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 SURGEON IMPLANTED INTRAOCULAR LENS ON (B)(6) 2022. BUT, THE PATIENT COMPLAINED ABOUT NEAR VISION AND POST-OP UNCORRECTED NEAR VISUAL ACUITY (UNVA) WAS J10. VISION PRE-OPERATIVE: FAR: 0.2 (DECIMAL), NEAR: J5 AND VISION POST-OPERATIVE:FAR: 0.3 (DECIMAL), NEAR: J5. FOR THIS REASON, THE SURGEON DECIDED TO EXPLANT THE IOL AND REPLACED IT FOR HOYA LENS ON (B)(6) 2022. NOW, POST-OP UNVA IS J5 AND THE PATIENT SEEMS TO BE SATISFIED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65789 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474726352

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention