BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 7856623 · Received September 7, 2018

    Report

    Report Number
    2648035-2018-01223
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    August 7, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION 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-(B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SERIAL#: UNKNOWN/NOT PROVIDED. CATALOG#: A COMPLETE CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN REVIEW THE INITIAL MDR 2648035-2018-01223, THE MANUFACTURING SITE ADDRESS WAS INCORRECTLY REPORTED AS ROAD 402 NORTH, KM 4.2, ANASCO INDUSTRIAL PARK, ANASCO, PUERTO RICO 00610. THE CORRECT MANUFACTURING SITE ADDRESS IS: VAN SWIETENLAAN 5, GRONINGEN 9728 NX, NL. THIS HAS BEEN UPDATED AND CORRECTED. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INTRAOCULAR LENS WAS NOTICED ROTATED POST IMPLANTATION. REPORTEDLY, THE LENS WAS AT 50 DEGREES ONE DAY POST-OP AND IT WAS MEASURED AT 20 DEGREES SEVEN DAYS POST-OP. THE PATIENT EXPERIENCED BLURRY VISION AND THE LENS WAS REPOSITIONED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. THERE WAS NO SIGNIFICANT AFFECT TO THE PATIENT ABILITY TO PERFORM DAILY ACTIVITIES. NO ADDITIONAL PROCEDURES WERE PERFORMED. THE LENS SERIAL NUMBER WAS ALSO PROVIDED. THE FOLLOWING WERE THEREFORE UPDATED: DATE OF EVENT: (B)(6) 2018. EXPIRATION DATE: 10/12/2019. SERIAL NUMBER: (B)(4). UDI NUMBER: (B)(4). CATALOG NUMBER: ZCT300U220. DEVICE MANUFACTURE DATE: 10/12/2015. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE AS TO DATE IT REMAINS IMPLANTED; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE 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 DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED UNEXPECTED POSTOP REFRACTION IN HER RIGHT EYE (OD) AFTER IMPLANTING ZCT300 TORIC INTRAOCULAR LENS (IOL). AS A RESULT, THE SURGERY CENTER WAS PLANNING FOR LENS EXCHANGE VS LENS ROTATION ON (B)(6) 2018. PRE-OP REFRACTION: +1.75 -4.00 X 110, POST-OP REFRACTION: +1.50 -2.50 X 80, BASED ON HER MEDICAL HISTORY, PATIENT HAD CHRONIC ANGLE CLOSURE GLAUCOMA. UCVA(UNCORRECTED VISUAL ACUITY) 20/70 BCVA (BEST CORRECTED VISUAL ACUITY): 20/70. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699199 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other