BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 17302675 · Received July 11, 2023

    Report

    Report Number
    3012236936-2023-01612
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 16, 2023
    Report Date
    March 25, 2024
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER AND WERE EVALUATED. NO IMAGES OF THE CARTRIDGE OR LENS STUCK IN THE CARTRIDGE WERE RECEIVED. BASED ON THE PHOTOGRAPHS PROVIDED, NO ISSUES WITH THE LENS COULD BE OBSERVED AND NO FURTHER EVALUATION WAS PERFORMED. IN ADDITION, AS PART OF THE INVESTIGATION, PRODUCT EVALUATION WAS PERFORMED ON UNUSED SAMPLES PROVIDED BY THE CUSTOMER. FIVE (5) SEALED UNITS WERE VISUALLY INSPECTED UNDER MAGNIFICATION. DUE TO THE HIGH INCIDENCE OF COMPLAINTS WITHIN THE SAME PRODUCTION ORDER, ADDITIONAL TESTING WAS REQUESTED TO THE MANUFACTURING SITE TO FURTHER INVESTIGATE THIS ISSUE. DYE AND TORQUE TEST WAS PERFORMED WITH FORTY (40) UNUSED UNITS. TESTING RESULTS SHOWED THAT 5 OUT OF 40 OF THOSE SAMPLES DID NOT MEET MANUFACTURING SPECIFICATIONS. OF THOSE FIVE (5) UNITS, TWO (2) UNITS FAILED TORQUE TEST AS THE LENS GOT STUCK IN THE CARTRIDGE AND THREE (3) FAILED DYE TEST (NO COATING WAS IDENTIFIED IN THE TIP OF THE CARTRIDGE). CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, A PRODUCT DEFICIENCY AND MALFUNCTION WERE IDENTIFIED. THEREFORE, FURTHER INVESTIGATION WAS REQUIRED AND NR-0210275 WAS INITIATED. ONCE THE NC IS COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED. THE PROVIDED PHOTOGRAPHS WERE EVALUATED AND FOUND NO ISSUES WITH THE IOL AND NO ADDITIONAL PHOTOGRAPHS WERE RECEIVED. IF THE PRODUCT IS RECEIVED AFTER CLOSURE, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY. THE COMPLAINT ISSUE OF STUCK IN CARTRIDGE COULD NOT BE CONFIRMED DURING PRODUCT EVALUATION, AND NO ISSUES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED IN THE INITIAL SURGERY AND THE 1MTEC30 IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED IN THE INITIAL SURGERY AND THE 1MTEC30 IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER:(B)(6). SECTION H3 - OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGERY WAS CANCELED BECAUSE THE INTRAOCULAR LENS (IOL) WAS STUCK IN CARTRIDGE AND THEY NEEDED TO REMOVE IT. THROUGH FOLLOW-UP WE LEARNED THAT THE IOL WAS LIKELY PUSHED THROUGH AFTER IT WAS STUCK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233110 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB JOHNSON & JOHNSON VISION CARE, INC. - US 1MTEC30 CM14304 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN LENS