BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7568167 · Received June 5, 2018

    Report

    Report Number
    9614546-2018-00535
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    May 1, 2018
    Report Date
    August 15, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474606876
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE. 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.

    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 ZXT375 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE PRE-OPERATIVE SYMFONY TORIC CALCULATOR RECOMMENDED A MODEL OF ZXT375 LEAVING RESIDUAL CYLINDER +0.94 AXIS 83. ALSO, AK X 90 WAS PERFORMED FOR PREDICTED RESIDUAL CYLINDER. INTRA-OPERATIVE OCULAR RESPONSE ANALYZER (ORA) RECOMMENDED 15.0 DIOPTER. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT HAD RESIDUAL ASTIGMATISM AND A FLIPPED AXIS NOTED AT THEIR OFFICE VISIT WITH THE DOCTOR ON (B)(6) 2018. A PRE-OPERATIVE MEASUREMENT WAS DONE AGAIN USING THE SYMFONY TORIC CALCULATOR, WHICH RECOMMENDED ZXT300 WITH PREDICTED RESIDUAL CYLINDER +0.03 AXIS 61. INTRA-OPERATIVE OCULAR RESPONSE ANALYZER (ORA) MEASUREMENTS AFTER REMOVAL OF ORIGINAL LENS RECOMMENDED 15.5 DIOPTER, BUT STILL RECOMMENDED ZXT375. HOWEVER, THE DOCTOR CHOSE A ZXT300 15.5 DIOPTER LENS AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411983 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT375 05050474606876

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention