BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 7581357 · Received June 8, 2018

    Report

    Report Number
    9614546-2018-00553
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Report Date
    September 21, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474609891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 5/22/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AND THE LENS WAS STUCK BEHIND THE STICKER (PATIENT LABEL) ON THE DAISY WHEEL. VISUAL INSPECTION SHOWS THAT THE LENS IS DIRTY. ADDITIONAL EVALUATIONS BY AN SME (SUBJECT MATTER EXPERT), UNDER 12X MAGNIFICATION, FOUND THAT THE LENS WAS NOT DAMAGED. A PROBABLE CAUSE FOR THE REPORTED, OBSERVED DAMAGE BY THE PHYSICIAN IS THAT THE LENS WAS NOT CORRECTLY POSITIONED IN THE DAISY WHEEL, WHICH MAY HAVE CAUSED IT TO DEFORM. IT WAS ALSO NOTED THAT THE LENS WAS NOT DAMAGED ON THE EDGE OF THE OPTICS. THIS DEFORMATION IS REVERSIBLE IN NATURE. HAD THE PHYSICIAN WAITED A COUPLE OF MINUTES, THE LENS WOULD HAVE RE-ASSUMED ITS NATURAL FORM. THE DEFORMATION REPORTED WAS REVERSIBLE AND NOT PERMANENT. THIS MOST PROBABLY OCCURRED DURING PACKAGING OR IN TRANSIT. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: 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

    IF IMPLANTED; GIVE DATE: UNKNOWN IF LENS WAS IMPLANTED. IF EXPLANTED; GIVE DATE: UNKNOWN IF LENS WAS IMPLANTED THEREFORE, UNKNOWN IF EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZXR00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. ZXR00, WHICH FALLS UNDER PMA (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 THE ZXR00V INTRAOCULAR LENS (IOL) WAS CURVED. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425324 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00V 05050474609891

    Patients

    Seq Age Sex Outcome Treatment
    1