BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 9188878 · Received October 14, 2019

    Report

    Report Number
    2648035-2019-01094
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 10/29/2019. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE SAMPLE WAS EVALUATED BY A PRINCIPAL ENGINEER AND NO DAMAGES OR FLAWS WERE OBSERVED. THE COMPLAINT REPORTED WAS NOT VERIFIED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. IN ADDITION, PHOTOS WERE PROVIDED AND WERE REVIEWED. THE PHOTO SHOWS AS PER CUSTOMER INFORMATION TWO CASES WITH THE FLAKE (DEBRIS/PARTICLE) SITTING ON POSTERIOR ASPECT OF THE LENS. HOWEVER, THE ORIGIN OR THE SOURCE OF THE MATERIAL IS UNKNOWN. BASED ON THE SAMPLE EVALUATION THAT WAS RETURNED, NO DAMAGES WERE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL INVESTIGATIONS WERE RECEIVED RELATED TO THIS PRODUCTION ORDER. CONCLUSION: 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.

    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 · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, NOT PROVIDED. BEST ESTIMATE (B)(6) 2019. IF IMPLANTED; IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR IS SEEING AN INCREASE IN PLAQUES COMING FROM THE CARTRIDGES AT TIME OF LENS INJECTION. MAYBE 50% OF RECENT CASES. THE DOCTOR SHARED TWO (2) SPECIFIC CASE IMAGES THAT OCCURRED RECENTLY WITH A FLAKE OF MATERIAL THAT GOES IN FROM THE INJECTOR WITH THE LENS. IT WAS ALSO STATED THAT THE DEBRIS IS EASY TO TAKE OUT BY IRRIGATION AND ASPIRATION (IA). FOLLOW-UP NOTED THAT THEY HAVE HAD THIS ISSUE BEFORE (APPROX. 2 YEARS AGO) AND IT WENT AWAY FROM SOME TIME AND MANIFESTED AGAIN AROUND THE BEGINNING OF SUMMER, BUT NO EXACT DATES OR OTHER SPECIFIC INFORMATION PROVIDED. IT WAS LEARNED THAT ALL PATIENTS HAD NO ADVERSE EVENTS AND ONE OF THE DOCTOR¿S COLLEAGUES DID LEAVE IT IN THE EYE AND THE PATIENT WAS FINE. NO OTHER INFORMATION WAS PROVIDED. 2 MDR REPORTS ARE REQUIRED, ONE FOR EACH CASE REPORTED. THIS MDR IS TO CAPTURE CASE#1. ANOTHER MDR IS SUBMITTED TO CAPTURE CASE #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981050 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 CE06376 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1