BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 10544914 · Received September 17, 2020

    Report

    Report Number
    2648035-2020-00692
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 21, 2020
    Report Date
    October 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474579071
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION INDICATED THAT THE COMPLAINT PRODUCT MAY BE THE CARTRIDGE AND NOT THE LENS. CORRECTED INFORMATION: THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY AS THE CARTRIDGE WAS INDICATED TO BE THE POTENTIAL COMPLAINT DEVICE: SECTION D1: BRAND NAME: PLATINUM 1 SERIES SECTION D2: PRODUCT CODE: KYB SECTION D3: COMMON DEVICE NAME: SURGICAL ADJUNCTS SECTION D4: MODEL #: 1MTEC30 SECTION D4: CATALOG #: 1MTEC30 SECTION D4: LOT#: CH03080 SECTION D4: EXPIRATION DATE: 2/12/2021 SECTION D4: UNIQUE IDENTIFIER: (B)(4).SECTION D6: IMPLANT DATE: NOT APPLICABLE AS THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. SECTION D7: EXPLANT DATE: NOT APPLICABLE AS THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. SECTION D11: CONCOMITANT MEDICAL PRODUCTS: TECNIS SYMFONY LENS, MODEL ZXR00, SN: (B)(4). SECTION G5: PMA/510(K) #: K081545 SECTION H4: DEVICE MANUFACTURE DATE: 2/12/2020 DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS AND RELATED DOCUMENTS FOR THE PRODUCTION ORDER OF THE DEVICE WERE REVIEWED AND NO DEVIATIONS OR DISCREPANCIES WERE FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE UNITS WERE MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER NUMBER. 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 · 1

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED, AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT EVENT REPORTED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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 AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR NOTICED SOMETHING STICKY ON THE BACK SIDE OF THE INTRAOCULAR LENS (IOL) IMPLANTED IN A PATIENT'S RIGHT EYE. THE SUBSTANCE WAS DIFFICULT TO REMOVE, BUT THEY WERE ABLE TO PULL IT OFF THE IOL, SO IT WAS CLEARLY STUCK TO IT BEFORE THE IOL WAS INSERTED. THE DOCTOR WAS ABLE TO KEEP THE SAME LENS IN THE PATIENT'S EYE AND DID NOT HAVE ANY OTHER ISSUES. REPORTEDLY, THE SCRUB TECH DID NOT SEE ANYTHING ON THE LENS BUT IT WAS NOTED THAT THE SUBSTANCE WAS SO SMALL THAT IT COULD NOT BE SEEN UNLESS UNDER A MICROSCOPE. THEY DID NOT SEE ANYTHING ON THE CARTRIDGE BEFORE THE SURGERY. THEY SENT THE FOREIGN SUBSTANCE TO PATHOLOGY; HOWEVER, IT WAS LATER INDICATED THAT THE SPECIMEN RETRIEVED WHICH WAS A VERY TINY PIECE DID NOT SURVIVE PROCESSING AT THE PATHOLOGY LAB. IT WAS NOTED THAT THE CONCOMITANT DEVICE, CARTRIDGE WAS ALSO DISCARDED BY THE ACCOUNT. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED AND NO SUTURES WERE USED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS CONFIRMED THAT THE PATIENT WAS FINE AND NOT EFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015530 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 CH03080 05050474579071

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CARTRIDGE, MODEL 1MTEC30, LOT# CH03080| TECNIS SYMFONY LENS, MODEL ZXR00, SN (B)(4).| CARTRIDGE, MODEL 1MTEC30, LOT# CH03080