BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 10659758 · Received October 9, 2020

    Report

    Report Number
    2648035-2020-00752
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    February 4, 2020
    Report Date
    November 13, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474552166
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RETURNED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PO NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT EYE DUE TO MYOPIA INTERFERING WITH ABILITY OF DRIVING. THERE WAS NO OTHER MEDICAL INTERVENTION AND THE PREVIOUS LASIK DID NOT CONTRIBUTE TO PATIENT BEING MYOPIC. THERE WAS NO OTHER MEDICAL HISTORY THAT LED TO THE ISSUE. THE PATIENT IS SOMEWHAT BETTER POST-OP. THE PROCEDURE WAS COMPLETED USING DIFFERENT LENS OF DIFFERENT DIOPTER POWER. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121570 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT150 05050474552166

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention