BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 21377189 · Received February 13, 2025

    Report

    Report Number
    3012236936-2025-000014
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    December 19, 2024
    Report Date
    April 17, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION E1 - TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. SECTION H6 - DEVICE CODE(S): 3191: NO CODE AVAILABLE (DISSATISFACTION - QUALITY/DESIGN). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO FURTHER DETAIL HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA AND ADDITIONAL INFORMATION: UPON FURTHER REVIEW, IT WAS NOTED THAT THE INFORMATION PROVIDED IN THE INITIAL MDR SHOULD BE UPDATED AS CUSTOMER INDICATED THAT THE SURGERY WAS DELAYED 5 TO 10 MINUTES. THEREFORE, THIS SUPPLEMENTAL FILING IS TO UPDATE THE FOLLOWING FIELDS: SECTION B5 - DESCRIBE EVENT OR PROBLEM: THERE WAS A DELAY OF 5 TO 10 MINUTES. SECTION H6 - HEALTH EFFECT - IMPACT CODE: 4632 - PROLONGED SURGERY ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAS BEEN REPORTED TO BE DISCARDED, DUE TO A CRACK IN THE LENS. IT IS UNKNOWN IN THERE WAS PATIENT CONTACT OR IF ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THROUGH FOLLOW-UP, WE LEARNED, THAT THE LENS WAS NOT IN CONTACT WITH THE PATIENT'S EYE, ONLY THE CARTRIDGE. THE ISSUE WAS NOTICED WHEN INSERTING THE LENS. THE ACCOUNT ALSO INDICATED THAT THE PLUNGER WAS SLOW TO SCREW AND THE PLUNGER WAS UNSCREWED OUTSIDE THE PATIENT'S EYE, THE LENS PRESENTED A TEAR AND THE CARTRIDGE TIP PRESENTED A CRACK. THE PATIENT WAS IMPLANTED WITH A DIFFERENT LENS DURING THE SAME PROCEDURE. THE LENS WAS LOADED ACCORDING TO THE INSTRUCTIONS FOR USE AND THE ACCOUNT INDICATED THAT THE NURSE LOADED THE IOL. WHEN THE CARTRIDGE TIP WAS INSERTED INTO THE PATIENT'S EYE INCISION, AND THE LENS WAS PUSHED FORWARD WITH THE PLUNGER, THE IOL WAS STUCK. THE PHYSICIAN REMOVED THE TIP FROM THE PATIENT'S EYE AND WHEN MANUALLY FORCING THE INJECTOR, THE TIP BENT UP AND INJECTOR PISTON PENETRATED THE PLASTIC CARTRIDGE UNDER THE LENS. THE ACCOUNT ALSO INDICATED THAT THE CARTRIDGE TIP WAS TOO SMALL FOR THE LENS TO BE DEPLOYED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE CARTRIDGE. THE LENS INVOLVED DOES NOT MEET REPORTABILITY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637503 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. 1MTEC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ZCB00 LENS, SN: (B)(6)