BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8486237 · Received April 5, 2019

    Report

    Report Number
    2648035-2019-00427
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    SERIAL#''S: UNKNOWN/NOT PROVIDED. CATALOG#''S: UNKNOWN, AS PRODUCT SERIAL NUMBERS WERE NOT PROVIDED. EXPIRATION DATE(S): UNKNOWN AS PRODUCT SERIAL NUMBERS WERE NOT PROVIDED. UDI #''S: UNKNOWN AS PRODUCT SERIAL NUMBERS WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). NO INDICATION THAT THE LENSES WERE EXPLANTED. DEVICE MANUFACTURE DATE(S): UNKNOWN AS PRODUCT SERIAL NUMBERS WERE NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE; THEREFORE, THE COMPLAINT ISSUE REPORTED WAS NOT VERIFIED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT 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

    A SURGEON REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENSES (MODEL PCB00), ABOUT 1/3 OF THE TIME HE VISUALIZES A SMALL STIFF SLIVER OF RESIDUAL PLASTIC MATERIAL EXITING THE TIP OF THE PRELOADED DELIVERY SYSTEMS. HE DETAILS THIS AS A MICROSCOPIC SLIVER OF OPAQUE/WHITE PLASTIC MATERIAL THAT EXITS THE INJECTOR WITH THE LENS SOMETIMES. REPORTEDLY, THE SURGEON CATCHES IT EVERY TIME AND REMOVES THE PLASTIC PIECE/SLIVER WITH AN INSTRUMENT AND PROCEEDS WITH HIS CASES WITHOUT INCIDENT. THE SURGEON ALSO COMMENTED THAT HE HAS NEVER EXPERIENCES AN ADVERSE PATIENT EVENT OR INJURY. THE PRELOADED DEVICES HAVE BEEN DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279973 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1