BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9398921 · Received December 2, 2019

    Report

    Report Number
    2648035-2019-01270
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558328
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NEITHER THE PRODUCT NOR THE ALLEGED COLORED PARTICLE DESCRIBED BY THE CUSTOMER ASSOCIATED TO THE COMPLAINT HAS NOT BEEN RECEIVED. EVALUATION WAS PERFORMED BASED ON THE VIDEO PROVIDED, IT CAN BE OBSERVED THE PHACOEMULSIFICATION PROCESS AND LENS INSERTION. A COLORED (YELLOWISH) MATERIAL OF INTEREST APPARENTLY EXPELLED THRU A NON AMO PUERTO RICO MANUFACTURING JOHNSON AND JOHNSON SURGICAL VISION IRRIGATION TOOL DURING AN IRRIGATION. SINCE THE OBSERVED FOREIGN MATERIAL REPORTED IN THE COMPLAINT CANNOT BE EVALUATED IT CANNOT BE CONFIRMED AS PRELOADED DEVICE MANUFACTURING PROCESS RELATED. THEREFORE, THE REPORTED COMPLAINT CANNOT BE CONFIRMED AS MANUFACTURING PROCESS RELATED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED NO ADDITIONAL INVESTIGATION REQUEST (IR) FOR THE PRODUCTION ORDER HAS 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED.  PHONE: UNKNOWN, INFORMATION NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERFECT PREPARATION AND IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THE DOCTOR THOUGHT THAT SHE SAW A LENS-COLORED PARTICLE WHICH LOOKED LIKE IT CAME FROM THE SHOOTER (DELIVERY SYSTEM) ENTER THE EYE DURING IMPLANT. THE DOCTOR REMOVED IT OUT OF THE EYE BY IRRIGATING/ASPIRATING. NO PATIENT INJURY OR WOUND ENLARGEMENT OCCURRED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191904 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558328

    Patients

    Seq Age Sex Outcome Treatment
    1 HEALON PRO, 0.85 ML, LOT UNKNOWN.