BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8997533 · Received September 11, 2019

    Report

    Report Number
    9614546-2019-00853
    Event Type
    Injury
    Date Received
    September 11, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE SERIAL NUMBER, MODEL NUMBER OF THE DEVICE, THE GENDER AND DATE OF BIRTH OF THE PATIENT WERE PROVIDED. IT WAS ALSO REPORTED THAT PRE-OP BSCVA: PRIOR TO THE ORIGINAL CAT SX: 20/20- AND POST-OP BSCVA: AFTER ORIGINAL CATARACT SX: ANYWHERE FROM 6/15 TO 6/60. THE SURGEON DECIDED TO PIGGYBACK THE IOL USING THE SENSAR AR40M LENS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS THAT WERE PREVIOUSLY REPORTED AS UNKNOWN HAVE NOW BEEN UPDATED ACCORDINGLY. SECTION A2: AGE/DATE OF BIRTH: (B)(6) 1961 AND SECTION A3: SEX/GENDER: FEMALE. SECTION D4: SERIAL NUMBER: (B)(6), SECTION D4: MODEL NUMBER: ZXT225, SECTION D4: CATALOG NUMBER: ZXT225U235, SECTION D4: EXPIRATION DATE: 9/1/22 AND SECTION D4: UDI NUMBER: (B)(4). SECTION D6: IF IMPLANTED, GIVE DATE: (B)(6) 2018. SECTION G5: PMA/510(K)#: P980040. SECTION H4: DEVICE MANUFACTURE DATE: 9/1/17. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE; PRODUCT TESTING COULD NOT BE PERFORMED, AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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 · 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

    AGE/DATE OF BIRTH: UNKNOWN, SEX/GENDER: UNKNOWN, DATE OF EVENT: UNKNOWN, MODEL NUMBER: UNKNOWN, CATALOG NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN, SERIAL NUMBER: UNKNOWN, UDI NUMBER: UNKNOWN. IF IMPLANTED, GIVE DATE: UNKNOWN. IF EXPLANTED; GIVE DATE: UNKNOWN, IF LENS WAS EXPLANTED OR REMAINS IMPLANTED. EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. PMA/510(K) #: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT APPROXIMATELY 9 MONTHS POST-OPERATIVE HAS RESIDUAL REFRACTIVE ERROR. THEREFORE, THE SURGEON WAS CONTEMPLATING BETWEEN A PIGGYBACK LENS OR A INTRAOCULAR LENS (IOL) EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790505 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention