BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7449651 · Received April 21, 2018

    Report

    Report Number
    9614546-2018-00365
    Event Type
    Injury
    Date Received
    April 21, 2018
    Report Date
    June 27, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605237
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: (B)(6) 2017. IF EXPLANTED, GIVE DATE: (B)(6) 2018. PATIENT CODE (B)(4). PER FOLLOW-UP INFORMATION, PATIENT COMPLAINED OF "SPIDER WEB" EFFECT ON HIS LEFT EYE (OS) AROUND LIGHTS ALONG WITH HALOS AND WAS UNABLE TO DRIVE AT NIGHT. FOR THESE REASONS, IOL HAD TO BE REMOVED. PER ACCOUNT, THE PATIENT WAS FIRST EXAMINED ON (B)(6) 2017. IT WAS NOTED THAT PATIENT HAD NO CONTRIBUTING MEDICAL HISTORY, NO PATIENT INJURY AND NO SECONDARY SURGICAL INTERVENTION REQUIRED. LENS WILL NOT BE RETURNED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE VERIFIED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORDS WERE REVIEWED AND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A COMPLAINT HISTORY SEARCH REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER TO DATE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. HOWEVER, THE LENS IS PLANNED TO BE EXPLANTED ON (B)(6) 2018. (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 ZXT150 21.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. HOWEVER, THE LENS IS PLANNED TO BE EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292307 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474605237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention