BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18918381 · Received March 15, 2024

    Report

    Report Number
    3012236936-2024-00567
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Report Date
    March 15, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE/DATE OF BIRTH (YEARS): AGES ARE 69.6 8.7. SECTION A3: SEX/GENDER: (MALE: FEMALE): 19:20. SECTION A4 & A5: INFORMATION UNKNOWN, NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. SECTION D4: A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL LOT/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. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: HU DONGRUI, LI QI, JIN GANYING, ZENG QINSEN, DETERMINATION AND EVALUATION OF EFFICACY AND ROTATIONAL STABILITY OF TWO TORIC INTRAOCULAR LENSES, (2023), CHINESE JOURNAL OF EXPERIMENTAL OPHTHALMOLOGY; VOL. 41, NO. 12: 1187 TO 1195. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: DETERMINATION AND EVALUATION OF EFFICACY AND ROTATIONAL STABILITY OF TWO TORIC INTRAOCULAR LENSES. A COHORT STUDY WAS DONE TO OBJECTIVELY EVALUATE THE POSTOPERATIVE EFFICACY AND ROTATIONAL STABILITY OF TWO COMMON TYPES OF TORIC INTRAOCULAR LENSES (IOLS), AND PERFORM VECTOR ANALYSIS OF POSTOPERATIVE RESIDUAL ASTIGMATISM. A TOTAL OF 80 EYES OF 80 PATIENTS WITH AGE-RELATED CATARACT COMBINED WITH REGULAR CORNEAL ASTIGMATISM UNDERWENT PHACOEMULSIFICATION COMBINED WITH TORIC IOL IMPLANTATION WITH EITHER THE TECNIS ZCT IOL (ZCT150 TO ZCT400; JOHNSON & JOHNSON VISION) (N=39 EYES) OR THE ACRYSOF IQ TORIC IOL (SN6AT4 TO SN6AT6; ALCON) (N=41 EYES). AT 3-MONTHS POST-OP, IT WAS REPORTED THAT THE PERCENTAGE OF EYES WITH DEVIATION OF LENS AXIS (LAD) OF = 5 DEGREES WAS 71.8% (N=28 EYES) AND THE PERCENTAGE OF EYES WITH LAD OF = 10 DEGREES WAS 94.9% (N=37 EYES) IN THE TECNIS GROUP. IT WAS ALSO REPORTED THAT THERE WERE TWO CASES IN THE TECNIS GROUP WITH AN LAD OF 12°, BUT NO SURGICAL REPOSITIONING WAS PERFORMED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320427 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. ZCT400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown