BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8333522 · Received February 12, 2019

    Report

    Report Number
    9614546-2019-00115
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND CORRECTIVE INFORMATION: BRAND NAME: UPDATED FROM UNKNOWN TO TECNIS 1-PIECE. PRODUCT CODE: UPDATED FROM MFK TO HQL. COMMON DEVICE NAME: UPDATED FROM MULTIFOCAL IOL TO MONOFOCAL IOL. MODEL #: UPDATED FROM UNKNOWN TO ZCB00. CATALOG #: UPDATED FROM UNKNOWN TO ZCB0000205. EXPIRATION DATE: UPDATED FROM UNKNOWN TO 12/30/2021. SERIAL NUMBER: UPDATED FROM UNKNOWN TO (B)(4). UDI #: UPDATED FROM (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AS THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE. A PRODUCT QUALITY DEFICIENCY COULD NOT BE CONFIRMED. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED, THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT, OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. THE REPORTED ISSUE WAS NOT 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 · 1

    BRAND NAME: IS UNKNOWN AS INFORMATION WAS NOT PROVIDED. MODEL#: MODEL NUMBER IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CATALOG#: CATALOG NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI#: UDI NUMBER IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE. THE DEVICE IS NOT RETURNING FOR EVALUATION AS TO DATE IT REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE SERIAL NUMBER FOR THE DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A STUDY INTRAOCULAR LENSES (IOL) UNKNOWN MODEL, WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018. PATIENT COMPLAINS OF HALOS, DIFFICULTY TELLING TIME, MULTIPLE OR DOUBLE VISION, SOMETIMES READING GETS TIRING, AND SENSITIVITY TO LIGHT THAT SHE CAN'T OPEN CURTAINS OR BLINDS TOO MUCH. THROUGH FOLLOW UP, THE CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE SYMPTOMS INTERFERE WITH NORMAL DAILY ACTIVITIES. THE PATIENT REPORTED THE SYMPTOMS INITIALLY AT THE ONE-MONTH POST-OP VISIT BUT HAD NO DIFFICULTY WITH ANY OF THEM. PRE-OP BCVDA WAS 20/25 AND AT SIX-MONTHS POST-OP BCVDA 20/16. THE PATIENT DID COMPLAIN OF PAINT AND IS NOT ON ANY OCULAR MEDICATIONS. NO SURGICAL INTERVENTION IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT CAPTURES PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OCULAR DEXTER (RIGHT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126977 TECNIS 1-PIECE MONOFOCAL IOL HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other