BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7043130 · Received November 17, 2017

    Report

    Report Number
    9614546-2017-01120
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474605213
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE OF EVENT IS UNKNOWN BUT BEST ESTIMATE IS BETWEEN (B)(6) 2017. IF EXPLANTED; GIVE DATE: NOT APPLICABLE; HOWEVER A PLANNED EXPLANT WAS REPORTED FOR (B)(6) 2017. PATIENT CODE OF (B)(4) IS PROVIDED FOR PLANNED EXPLANT OF THE INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S OPERATIVE EYE WAS THE RIGHT EYE (OD). THE PLANNED EXPLANT WAS POSTPONED DUE TO THE PATIENT POSTPONING THE PROCEDURE AND THEN CANCELLING THE DAY BEFORE PROCEDURE WAS TO TAKE PLACE. THE PHYSICIAN¿S NAME IS DR. (B)(6). BASED ON THE ADDITIONAL INFORMATION RECEIVED THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: INITIAL REPORTER NAME: DR. (B)(6). HEALTH PROFESSIONAL: YES OCCUPATION: PHYSICIAN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE AS IT REMAINS IMPLANTED. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A TECNIS SYMFONY TORIC MODEL ZXT150 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS PLANNED FOR EXPLANT FROM A PATIENT¿S OPERATIVE EYE AS THERE WAS DISSATISFACTION WITH THE PATIENT¿S NEAR VISION AND EXPERIENCING HALOS. THE PATIENT WAS INITIALLY TREATED WITH EYE DROPS AND ARTIFICIAL TEARS BUT WAS NOT SATISFIED. THE PLANNED EXPLANT WAS FOR AN EXCHANGE WITH A STANDARD IOL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822706 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT150 05050474605213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention