BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 17253014 · Received July 3, 2023

    Report

    Report Number
    3012236936-2023-01607
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 21 JULY 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT CARTRIDGE PRESENTED WITH A CRACKED CARTRIDGE TIP. A PIECE OF CARTRIDGE WAS TAPED TO A PICTURE. THE DEVICE PRESENTED WITH A RED COLOR THROUGH THE TUBE AND TIP THAT WAS NOT PRESENT IN THE CUSTOMER PROVIDED PHOTOGRAPHS. THE COMPLAINT ISSUE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IMPLANT DATE : NOT APPLICABLE, AS THE UNFOLDER IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: EXPLANT DATE : NOT APPLICABLE, AS THE UNFOLDER IS NOT AN IMPLANTABLE DEVICE. SECTION E1: INITIAL REPORTER TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE TIP WAS FOUND BROKEN AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. THE BROKEN CARTRIDGE PIECE WAS IN THE ANTERIOR CHAMBER OF THE EYE. THE DOCTOR REMOVED THE BROKEN PIECE BY FORCEPS. THE IOL WAS NOT AFFECTED. THE SURGERY COMPLETED UNEVENTFULLY WITHOUT COMPLICATION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030421 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. 1MTEC30 CM10342 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown