BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 7367979 · Received March 23, 2018

    Report

    Report Number
    9614546-2018-00282
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    June 13, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED AS THE COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBERS OF THE LENSES WERE NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBERS WERE NOT PROVIDED. THERE IS NO INDICATION THAT THE LENSES WERE EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IN AN INTERVIEW FROM THE AMERICAN ACADEMY OF OPHTHALMOLOGY (AAO) 2017, A SURGEON DISCUSSED RESULTS OF A RETROSPECTIVE STUDY COMPARING THE ROTATIONAL STABILITY OF 2 TORIC INTRAOCULAR LENSES (IOLS). THE COHORT INCLUDED 628 CONSECUTIVE PATIENTS WHO RECEIVED THE ALCON ACRYSOF AND 648 WHO RECEIVED THE TECNIS TORIC IOLS AT A SINGLE CENTER. THE SURGEON NOTED THAT THIS STUDY DIFFERED FROM OTHER STABILITY COMPARISONS BECAUSE THE CENTER¿S PHYSICIANS USED THE CALLISTO DIGITAL MARKING SYSTEM TO CONFIRM THE FINAL IOL POSITION DURING ALL OPERATIONS. A RECENT INVESTIGATION FOUND THAT 28% OF POSTOPERATIVE MISALIGNMENT STEMS FROM MISALIGNMENT DURING THE PROCEDURE. THE SURGEON AND HIS COLLABORATOR, ANOTHER PHYSICIAN, FOUND THAT THOUGH BOTH IOLS SHOWED GOOD STABILITY PROFILES, A HIGHER PERCENTAGE OF PATIENTS WITH THE ALCON MODEL ACHIEVED ALIGNMENT WITHIN 10 DEGREES OR LESS COMPARED WITH THE TECNIS (98% VS. 93%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207950 TECNIS TORIC IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZCT

    Patients

    Seq Age Sex Outcome Treatment
    1