BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 7384107 · Received March 29, 2018

    Report

    Report Number
    2648035-2018-00432
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    February 21, 2018
    Report Date
    January 25, 2019
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. THE LENS REMAINS IMPLANTED. THE MODEL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: AS THE PRODUCT IDENTIFIERS HAVE NOW BEEN PROVIDED THE FOLLOWING FIELDS HAVE CORRECTED FROM WHAT WAS INITIALLY REPORTED: COMMON DEVICE NAME: MULTIFOCAL IOLS. (B)(4). ADDITIONAL INFORMATION: INFORMATION RECEIVED THAT THE CLINICAL STUDY WAS UNMASKED AND THE PRODUCT IDENTIFIERS WERE PROVIDED. AS A RESULT, THE FOLLOWING FIELDS THAT WERE PREVIOUSLY REPORTED AS UNKNOWN HAVE BEEN UPDATED. BRAND NAME: TECNIS, MODEL NUMBER: ZLB00, SERIAL NUMBER: (B)(4), CATALOG#: ZLB00U0220, EXPIRATION DATE: 09/21/2021, UDI NUMBER: (B)(4), PMA/510(K)#: P980040. DEVICE MANUFACTURE DATE: 09/21/2017. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN REVIEW, IT WAS NOTED THAT IN THE INITIAL REPORT THE TEXT INDICATED THE AFFECTED EYE WAS THE LEFT EYE, HOWEVER THIS IS INCORRECT. THE AFFECTED EYE WAS THE RIGHT EYE. ALSO, IN SECTION "DATE OF IMPLANT", IF IMPLANTED, GIVE DATE: THE DATE PROVIDED WAS (B)(6) 2018, HOWEVER THE CORRECT DATE IS (B)(6) 2018. THEREFORE, BOTH SECTIONS HAVE BEEN CORRECTED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY. IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE OF THE PATIENT ON (B)(6) 2018. IF IMPLANTED, GIVE DATE: (B)(6) 2018. ADDITIONAL INFORMATION: DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT REMAINS IMPLANTED. THE REPORTED COMPLAINT CANNOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. NO NON- CONFORMANCE REPORTS (NC) ASSOCIATED WITH THE PRODUCTION ORDER WERE FOUND. THE SEARCH IN THE COMPLAINT HISTORY REVEALED THAT NO ANOTHER COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE LABELING REVIEW WAS COMPLETED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDE INSTRUCTIONS, 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 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 THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE OF THE PATIENT ON (B)(6) 2018. REPORTEDLY, ON (B)(6) 2018, ONE HAPTIC WAS NOTED TO BE OUT OF POSITION, OUTSIDE OF THE CAPSULAR BAG. IT WAS NOT DAMAGED NOR WAS THE LENS DISLOCATED. A SECONDARY SURGICAL INTERVENTION WAS PERFORMED TO PLACE THE HAPTIC BACK INTO THE CAPSULAR BAG. NO VISUAL ISSUES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE OF THE PATIENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225960 TECNIS MULTIFOCAL MFK JOHNSON AND JOHNSON SURGICAL VISION, INC. ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention