BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 8360779 · Received February 22, 2019

    Report

    Report Number
    2648035-2019-00222
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474548718
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). TO DATE, THE LENS REMAINS IMPLANTED. (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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 SENSAR LENS MODEL, AAB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS VERY COLD DURING IMPLANTATION AS IT UNFOLDED LITTLE SLOWER THAN USUAL. IN ADDITION TO THE OUTER RIM OF THE LENS (THE NON-OPTIC PART), LENS REPORTEDLY SEEMED TO BE DENTED OR SCRATCHED AFTER IMPLANTATION. THERE WAS NO SIGNIFICANT DELAY DURING THE PROCEDURE NOR VISUAL ISSUES FOR THE PATIENT. AS A RESULT OF THE GOOD OUTCOME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154888 SENSAR MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. AAB00 05050474548718

    Patients

    Seq Age Sex Outcome Treatment
    1