BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 10334910 · Received July 28, 2020

    Report

    Report Number
    9614546-2020-00277
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    February 24, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474553729
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH# 9614546-2020-00277 EXPLAINED THERE WAS INCISION ENLARGEMENT IN B5. HOWEVER, INCISION ENLARGEMENT WAS NOT CODED IN H6. SECTION H6: PATIENT CODE, 3191: INCISION ENLARGEMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED REPORT INDICATING THE IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HYPEROPIC SURPRISE POST SURGERY. THE PATIENT EXPERIENCED VERY BLURRY VISION AT BOTH DISTANCE AND NEAR. THEIR VISUAL ACUITY PRE-OP IS 20/25 WITH CORRECTION AND POST-OP IS 20/70+. THE INCIDENT DATE WAS REPORTED AS (B)(6) 2020 AND HYPEROPIA WAS CONFIRMED (B)(6) 2020. WHEN THE IOL WAS EXPLANTED THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. THE IOL WAS REPLACED WITH ANOTHER IOL MODEL ZCT400, BUT HIGHER DIOPTER 14.0. THIS LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799174 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT400 05050474553729

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention