BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 9366425 · Received November 22, 2019

    Report

    Report Number
    9614546-2019-01060
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THE PRODUCT MODEL AND SERIAL NUMBER AS ZCB00 SERIAL NUMBER 9002801805. AS A RESULT OF RECEIVING PRODUCT IDENTIFIERS THE FOLLOWING FIELDS WERE POPULATED ACCORDINGLY: SECTION D1 - BRAND NAME: TECNIS 1-PIECE. SECTION D2 - PRODUCT CODE: HQL. SECTION D2 - COMMON DEVICE NAME: MONOFOCAL IOLS. ALSO, THE FOLLOWING INFORMATION HAS BEEN ENTERED: SECTION D4 - MODEL NUMBER: ZCB00. SECTION D4 - EXPIRATION DATE: 1/29/2022. SECTION D4 - CATALOG NUMBER: ZCB0000185. SECTION D4 - SERIAL NUMBER: (B)(6). SECTION D4 - UDI NUMBER: (B)(4). SECTION G5 - PMA# P980040. SECTION H4: MANUFACTURING DATE: 1/29/2018 SECTION H6: METHOD CODES, 3331, 4109, RESULTS CODE 213 MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORDS WERE EVALUATED, AND THE DEVICES WERE MANUFACTURED WITHIN SPECIFICATIONS. THE UNITS WERE RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED THIS PRODUCTION ORDER (P.O.) WAS PERFORMED ON JULY 15, 2020. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PO NUMBER. 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

    CORRECTED DATA: IN FOLLOW-UP REPORT #2 THE DATE 7/2/2020 WAS PROVIDED IN SECTION G4, HOWEVER ON (B)(6), 2020, IT WAS CLARIFIED WITH THE CLINICAL RESEARCH TEAM THAT ON (B)(6) 2020 THE DATABASE IS LOCKED WHICH MEANS THAT NO MORE DATA CAN BE ENTERED INTO THE STUDY. THE DATA HAD TO BE ANALYZED AND REVIEWED TO CORRELATE THE DEVICE AND PATIENT INFORMATION. THIS REVIEW WAS COMPLETED ON (B)(6) 2020, THEREFORE, THE CORRECT AWARE DATE FOR REPORTING PURPOSES IS (B)(6) 2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED. AS A RESULT, THE FOLLOWING FIELDS HAVE BEEN UPDATED: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES; SECTION D10: RETURNED TO MANUFACTURER ON: 2/25/2020. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. NO COSMETIC ISSUES WERE IDENTIFIED ON THE LENS HAPTICS. BASED ON THE CONDITION OF THE RETURN LENS NO ADDITIONAL PRODUCT EVALUATION COULD BE PERFORMED. COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: UNABLE TO REVIEW THE MANUFACTURING RECORDS AS THE SERIAL NUMBER IS UNKNOWN. 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

    BRAND NAME: UNKNOWN. MODEL NUMBER: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN, NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS A SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. PMA - UNKNOWN SINCE STUDY IS MASKED, PRODUCT IDENTIFIERS ARE NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS A SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION THE OPTIC OF THE INTRAOCULAR LENS (IOL) HAD A DEFECT CAUSED BY EITHER THE INJECTOR OR THE FOLDING TECHNIQUE. THERE WAS NO PATIENT COMPLICATION AND/OR INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION REPORTED THE DEFECT WAS A TORN HAPTIC. THE LENS WAS IMPLANTED AND REMOVED. THERE WAS NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157854 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR