BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16433664 · Received February 23, 2023

    Report

    Report Number
    3012236936-2023-00466
    Event Type
    Injury
    Date Received
    February 23, 2023
    Report Date
    February 23, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE DATE OF BIRTH (YEARS): AGES ARE 56.96 19.98. SEX GENDER: (MALE: FEMALE): 10:13. INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2022. EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: INCIDENCE AND RISK FACTORS OF REPOSITIONING SURGERY TO CORRECT MISALIGNMENT OF TORIC INTRAOCULAR LENSES AFTER CATARACT SURGERY:A SINGLE-CENTER RETROSPECTIVE OBSERVATIONAL STUDY A RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE INCIDENCE AND OUTCOMES OF REPOSITIONING SURGERY TO CORRECT MISALIGNMENT OF SEVERAL TORIC INTRAOCULAR LENSES (IOLS) AFTER CATARACT SURGERY. A TOTAL OF 1,135 EYES WERE IMPLANTED WITH TORIC IOLS AND WERE DIVIDED INTO THREE GROUPS: ACRYSOF SN6AT2-T9 (MONOFOCAL) OR SND1T2-T6 (MULTIFOCAL) (N=786 EYES; ALCON LABORATORIES INC.), ZEISS AT TORBI 709M (MONOFOCAL) OR AT LISA 909M (MULTIFOCAL) (N=169 EYES; CARL ZEISS MEDITEC AG) AND TECNIS ZCT100-400 (MONOFOCAL) OR ZMT150-400 (MULTIFOCAL) (N=180 EYES; ABBOTT MEDICAL OPTICS). IN PATIENTS IMPLANTED WITH TECNIS ZCT100-400 OR ZMT150-400, 13 PATIENTS REPORTED MISALIGNMENT AND HAD TO UNDERGO REPOSITIONING SURGERY. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: HONGLEI LI, JIAJUN SUN, HUIRAN BAI, LIN LENG, YUNHAI DAI, XIAOMING WU, INCIDENCE AND RISK FACTORS OF REPOSITIONING SURGERY TO CORRECT MISALIGNMENT OF TORIC INTRAOCULAR LENSES AFTER CATARACT SURGERY: A SINGLE-CENTER RETROSPECTIVE OBSERVATIONAL STUDY, (2022), KARGER; PAGE 1-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732256 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. ZCT225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention