BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8341812 · Received February 14, 2019

    Report

    Report Number
    9614546-2019-00122
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 21, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE INITIAL EMDR REPORT, "AGE" WAS NOT ADDRESSED; THEREFORE, IT HAS BEEN ADDRESSED IN THIS SUPPLEMENTAL REPORT. DATE OF BIRTH: UNKNOWN, NOT PROVIDED. ADDITIONAL INFORMATION: INFORMATION RECEIVED THAT THE CLINICAL STUDY WAS UNMASKED, AND THE PRODUCT IDENTIFIERS WERE PROVIDED. AS A RESULT, THE FOLLOWING FIELDS HAVE BEEN UPDATED. DATE OF EVENT: (B)(6) 2019. BRAND NAME: TECNIS 1-PIECE. SERIAL#: (B)(4). MODEL #: ZCB00. CATALOG#: ZCB0000230. EXPIRATION DATE: 1/26/2022. UDI #: (B)(4). MANUFACTURING SITE ADDRESS: LOT H.S (D) 70252, PT 2489, JALAN HI TECH 11, INDUSTRIAL Z, KULIM HI TECH PARK, 09000, MALAYSIA. PMA/510K: P980040. BASED ON THE CORRECTED MANUFACTURING SITE, THE MANUFACTURER REPORT NUMBER SHOULD BEGIN WITH (B)(4). DEVICE MANUFACTURE DATE: 1/26/2018. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINTS HISTORY REVEALED TWO ADDITIONAL INVESTIGATION REPORTS (IRS) RELATED TO THE SAME PRODUCTION ORDER NUMBER. THE REPORTED COMPLAINTS WERE NOT CONFIRMED IN EITHER OF THE IRS. 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 NR-0148919 AND CAPA: 010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE NOT PROVIDED ONLY THAT SYMPTOMS WERE REPORTED BY THE SUBJECT AT THE ONE MONTH VISIT. BRAND NAME: UNKNOWN/ NOT PROVIDED SERIAL#: UNKNOWN/NOT PROVIDED. MODEL #: UNKNOWN/NOT PROVIDED. CATALOG#: CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). TO DATE, THE LENS REMAINS IMPLANTED. PMA/510(K) #: UNKNOWN AS PRODUCT SERIAL NUMBER OR MODEL WAS NOT PROVIDED DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THERE WAS NO MODEL/LOT/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 REPORTED THAT A CLINICAL STUDY PATIENT (SUBJECT) WAS SEEN AT THEIR SIX-MONTH STUDY VISIT. THE PATIENT COMPLETED A BINOCULAR PATIENT-REPORTED VISUAL SYMPTOM QUESTIONNAIRE (PRVSQ) AND INDICATED BEING VERY BOTHERED WITH HALOS AND STARBURSTS AND MODERATELY BOTHERED BY LOW-LIGHT VISION. THESE SYMPTOMS CAUSED A LOT OF DIFFICULTY DRIVING AT DUSK AND AT NIGHT FOR THIS SUBJECT. THE SUBJECT ALSO COMPLAINED OF MILD SENSITIVITY TO LIGHT AND MODERATE GLARE THAT DID NOT CAUSE HER ANY DIFFICULTY. THE PRINCIPAL INVESTIGATOR (PI) AT THE SITE REVIEWED THE RESULTS AND INDICATED THAT THESE SYMPTOMS ARE DEVICE-RELATED. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) AT THE 6-MONTH VISIT FOR THE RIGHT EYE (OD) WAS 20/16. THERE WAS NO ADDITIONAL TREATMENT, AND THERE IS NO PLAN TO EXPLANT THE LENS. ALSO NOTED THE SUBJECT ALSO HAD SOME SYMPTOMS AT THE 1-MONTH VISIT ON (B)(6) 2018, INCLUDING BEING EXTREMELY BOTHERED BY HALOS, STARBURSTS AND GLARE, CAUSING DIFFICULTY WITH DRIVING (DIFFICULTY DRIVING AT NIGHT); AS WELL AS SENSITIVITY TO LIGHT AND POOR LOW LIGHT VISION, WHICH DID NOT CAUSE HER ANY DIFFICULTIES. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO THE RIGHT EYE (OD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131609 TECNIS 1-PIECE MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other