BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8558629 · Received April 26, 2019

    Report

    Report Number
    9614546-2019-00372
    Event Type
    Injury
    Date Received
    April 26, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE SERIAL NUMBER AND MODEL NUMBER OF THE DEVICE WAS PROVIDED ALONG WITH THE GENDER AND DATE OF BIRTH OF THE PATIENT. THEREFORE, THE FOLLOWING FIELDS THAT WERE PREVIOUSLY REPORTED AS UNKNOWN HAVE NOW BEEN UPDATED ACCORDINGLY. AGE/DATE OF BIRTH: (B)(6) 1944. SEX/GENDER: MALE. BRAND NAME: TECNIS 1 MULTIFOCAL. MODEL NUMBER: ZLB00. CATALOG NUMBER: ZLB00. EXPIRATION DATE: 6/10/2022. SERIAL NUMBER: (B)(4). UDI NUMBER: (B)(4). PMA/510(K) #: P980040. DEVICE MANUFACTURE DATE: 6/10/2018. 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. 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 PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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: EXACT DATE NOT PROVIDED, BEST ESTIMATE IS (B)(6) 2019 WHEN IT WAS LEARNED THERE WAS PLANNED INTERVENTION. BRAND NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE LENS REMAINS IMPLANTED. PMA/510(K) #: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. THERE WAS NO MODEL OR SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) LENS WAS GOING TO BE REPOSITIONED OR EXPLANTED. FURTHER INFORMATION WAS PROVIDED AND IT WAS LEARNT THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE AND NOT EXPLANTED. POST REPOSITIONING THE PATIENT IS DOING WELL WITH NO OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347817 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention