BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9892078 · Received March 27, 2020

    Report

    Report Number
    2648035-2020-00294
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 25, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558304
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SPECIMEN CONTAINER WAS RETURNED AND VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE. NO PARTICLE WAS OBSERVED INSIDE THE CONTAINER. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. PRODUCT DEFICIENCY COULD NOT BE DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND 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

    DEVICE EVALUATION: THE MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. (B)(6). 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 AFTER CORRECT SET-UP OF THE UNIT USING HEALON PRO AS PER DIRECTION FOR USE. DOCTOR DISCOVERED A PARTICLE LATER AND REMOVED IT WITHOUT EXPANDING WOUND OR ANYTHING. AS PER THE SURGEON IT IS UNCLEAR IF THE PARTICLE CAME FROM THE HEALON PRO OR THE IOL. NO FURTHER INFORMATION PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT IOL. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SUSPECT HEALON PRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353424 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558304

    Patients

    Seq Age Sex Outcome Treatment
    1 HEALON PRO LOT# UE31742