BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8893543 · Received August 14, 2019

    Report

    Report Number
    3011852734-2019-00168
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579163
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: THE RETURNED SAMPLE WAS RECEIVED ON 14-AUG-2019 AND REVEALED THAT THE LENS WAS INTACT WITH FOREIGN FIBER-LIKE MATERIAL OBSERVED ON THE SURFACE OF THE LENS. THE LENS WAS CLEANED AND DRIED WITH COMPRESSED AIR. VISUAL INSPECTION PROCEEDED WITH MAGNIFICATION AND REVEALED NO FURTHER DAMAGE TO THE LENS. THE REPORTED ISSUE CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED ANOTHER COMPLAINT THAT WAS NOT RELATED TO THIS REPORTED COMPLAINT WITHIN THE SAME PRODUCTION ORDER. 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 · 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 · 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 A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE. THIS WAS REPORTED BY THE PATIENT AS CONSTANT HALOS AROUND LIGHTS DURING THE DAY AND AT NIGHT. THE HALOS HAD THE APPEARANCE OF A SPIDER WEB AROUND ALL LIGHT SOURCES. THESE SYMPTOMS COULD NOT BE RESOLVED WITH SPECTACLES. IT WAS NOTED THAT THERE WAS INCISION ENLARGEMENT. THE EXPLANTED IOL WAS REPLACED WITH A AAB00 IOL, POWER +23.00. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688176 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579163

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention