BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 10909215 · Received November 26, 2020

    Report

    Report Number
    9614546-2020-00502
    Event Type
    Injury
    Date Received
    November 26, 2020
    Report Date
    November 25, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579187
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). LENS REMAINS IMPLANTED. (B)(4). DEVICE EVALUATION: PRODUCT EVALUATION CANNOT BE PERFORMED AS PER THE INITIAL REPORT, THE LENS REMAINS IMPLANTED. THE COMPLAINT ISSUE REPORTED 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 SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT 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

    THE PATIENT REPORTED THAT AFTER THE IMPLANTATION OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL) IN HER RIGHT (OD) EYE, HER VISION IMPROVED, BUT OVER TIME THIS VISION DECREASED. THE PATIENT EXPERIENCED STARBURSTS WHILE LOOKING AT LIGHTS, IN WHICH THE DOCTOR PERFORMED A PRK (PHOTOREFRACTIVE KERATECTOMY). THE PATIENT IS STILL EXPERIENCING THE STARBURSTS AND CANNOT DRIVE AS A RESULT. ALSO, WHEN TRYING TO READ, IT SEEMS THE LETTERS ARE ALL SMOOSHED TOGETHER, WHICH REQUIRES READING GLASSES. DRY EYE PRESCRIPTION DROPS AND PLUGS, RESTASIS AND XIIDRA WERE PRESCRIBED. LENS REMAINS IMPLANTED UNTIL SHE RECEIVED ADDITIONAL CONSULTATION FROM THE HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE LEFT (OS) EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374545 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention