BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16748077 · Received April 14, 2023

    Report

    Report Number
    3012236936-2023-00746
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    November 7, 2022
    Report Date
    April 18, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474546714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. SECTION E1: TELEPHONE NUMBER:(B)(6). SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE. TECNIS OPTIBLUE 1-PIECE IOL. THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. SECTION H6 DEVICE CODE 3191 IS PROVIDED FOR LATHE LINES. DEVICE EVALUATION: THE LENS WAS NOT RECEIVED FOR EVALUATION. THE CUSTOMER PROVIDED A MOVIE AND PHOTOGRAPHS WHICH WERE REVIEWED BY A MANUFACTURING SUBJECT MATTER EXPERT (SME) WHO DETERMINED THAT "BASED ON THE INTENSITY THAT CAN BE OBSERVED ON THE IMAGES SHARED, THE CONDITION SEEMS TO BE OUT OF SPECIFICATIONS, DUE TO THE DEEPNESS OBSERVED ON THE LINES". MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ASSIGNABLE CAUSE COULD BE DUE TO THE ACCEPTANCE OF A NON-CONFORMING LENS DURING VISUAL INSPECTION. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW OF THE FILE, IT WAS NOTED THAT THE FOLLOWING INVESTIGATION INFORMATION SHOULD BE INCLUDED IN THIS REPORT (MDR # 3012236936-2023-00746) CONCLUSION: A SEARCH OF COMPLAINTS RELATED TO THE PRODUCTION ORDER WAS PERFORMED FEBRUARY 13, 2023. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER (LOT). A SEARCH OF NON-CONFORMANCE (NC) AND CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS CONDUCTED ON MARCH 9TH, 2023. THE SEARCH REVEALED NO NC/CAPA RELATED TO THIS COMPLAINT. THERE ARE MANUFACTURING CONTROLS IN PLACE TO ENSURE IF MACHINE LINES EXCEED SPECIFICATIONS THEY MUST BE REJECTED. AN AWARENESS WAS CONDUCTED TO THE OPERATORS OF THE LENS GENERATION AND QUALITY INSPECTION AREAS INVOLVED IN THE PRODUCTION ORDER OF THE REPORTED COMPLAINT TO REINFORCE VISUAL INSPECTION DURING THE PROCESS, TO PREVENT RECURRENCE. THESE TYPES OF EVENTS WILL CONTINUE TO BE MONITORED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CHECKING THE CENTERING OF THE INTRAOCULAR LENS (IOL) IN THE EYE AFTER IMPLANTATION, THE SURGEON OBSERVED SHADOWS THAT LOOKED LIKE DIFFRACTION GROOVES ON THE PERIPHERAL PART OF THE OPTIC WHERE THE REFLECTED LIGHT HAD ILLUMINATED. THERE WAS NO REPORTED PATIENT INJURY OR HEALTH DAMAGE, INCLUDING POSTOPERATIVE VISUAL ACUITY. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806905 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V 05050474546714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown