BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8466621 · Received March 29, 2019

    Report

    Report Number
    9614546-2019-00276
    Event Type
    Injury
    Date Received
    March 29, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474604940
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 5/10/2019. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AND VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THAT THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. LABELING REVIEW: THE LABELING REVIEW WAS COMPLETED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDE INSTRUCTIONS, PRECAUTIONS, ALONG WITH WARNINGS 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN 8/24/2017 AND 3/14/2019. (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 PATIENT HAD BILATERAL SYMFONY TORIC IMPLANTS IN 2017. THE PATIENT THEN DEVELOPED GLARE AND JUST WANTS BOTH LENSES OUT. THE DOCTOR PLANNED ON PUTTING IN A STANDARD TORIC LENS BUT ADVISED THE PATIENT THAT IF THERE IS ANY ISSUE WILL GO WITH A STANDARD LENS. THE ZXT150 SYMFONY TORIC WAS REMOVED FROM HER LEFT EYE (OS) ON (B)(6) 2019. THE NEW INTRAOCULAR LENS (IOL) WAS A MODEL ZCT225, +8.00. NO VITRECTOMY OR SUTURES AND NO POST-OP INJURIES. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258344 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150 05050474604940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention