BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 11009171 · Received December 15, 2020

    Report

    Report Number
    2020664-2020-00059
    Event Type
    Injury
    Date Received
    December 15, 2020
    Report Date
    February 23, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474553200
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED, STATES THAT THE EXPLANT WAS PERFORMED, DUE TO IOL BEING MALPOSITION. PATIENT HAD ASTIGMATISM. AND ALSO TO MAKE PATIENT HAPPY. PATIENT WAS SEEN POST-OP ON (B)(6) 2020. AND IS IN EXCELLENT CONDITION DOING FINE AND HAPPY. AS A RESULT THE FOLLOWING FIELDS HAVE BEEN UPDATED: SECTION D6: DEVICE CODE: 2923; SECTION D6: PATIENT CODE: 2138; SECTION D6: PATIENT CODE: 4581. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING (B)(6) 2020. (B)(4). DEVICE EVALUATION: PRODUCT EVALUATION CANNOT BE PERFORMED AS PER THE INITIAL REPORT, THERE IS NO SUSPECT PRODUCT AVAILABLE TO SEND BACK FOR EVALUATION. 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 REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER 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. NOTE: THE DEVICE WAS MANUFACTURED AT THE (B)(4) SITE WHICH HAS BEEN CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE. THERE WAS NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED, NO SUTURES PERFORMED. NO PRESCRIPTION WAS GIVEN TO THE PATIENT OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. IT WAS STATED THAT THERE WAS NO LENS TO RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478317 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT300 05050474553200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention