BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 8103495 · Received November 26, 2018

    Report

    Report Number
    9614546-2018-01115
    Event Type
    Injury
    Date Received
    November 26, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474579156
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. 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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 12/7/2018. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE PRODUCT WAS RECEIVED DRY IN A LITTLE JAR. THE PRODUCT WAS DISINFECTED ACCORDING TO PROCEDURE WV0491. THE PRODUCT WAS INSPECTED BY A QUALIFIED INSPECTOR USING A MICROSCOPE WITH A 12X MAGNIFICATION. IT CAN BE SEEN THAT THE LENS IS CONTAMINATED, DUST PARTICLES ARE PRESENT. THIS IS EXPECTED AS THE LENS WAS TRANSPORTED FROM CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS BEING CUT IN, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. 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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS (B)(6) 2018. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +23.0 DIOPTER) HAD SHIFTED. THE PATIENT HAD SEVERE GLARE AFTER LENS IMPLANT ON (B)(6) 2018. PATIENT WAS GOING TO HAVE LENS EXPLANTED IN SECONDARY SURGERY ON (B)(6) 2018. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT LENS WAS EXPLANTED IN SECONDARY SURGERY BECAUSE THE PATIENT WAS EXPERIENCING A FOREIGN BODY SENSATION, A PERIPHERY SHADOW, AND GLARE. REPORTEDLY, THE LENS HAD DECENTERED. NEW LENS WITH MODEL Z9002 +21.0 DIOPTER WAS PLACED IN SULCUS AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DISCHARGED ON HOME SELF-CARE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942960 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00 05050474579156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention