BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 20483220 · Received October 18, 2024

    Report

    Report Number
    3012236936-2024-000282
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 18, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6: ADVERSE EVENT PROBLEM: CODE '4631 - MORE COMPLEX SURGERY' UPDATED TO '2199 - NO HEALTH CONSEQUENCES OR IMPACT'. AS THE CUSTOMER SUSPECTED THAT THE DEFECT OCCURRED WHILE LOADING, UPON FURTHER REVIEW, THE EVENT IS ASSESSED AS NOT REPORTABLE FOR THE CARTRIDGE PRODUCT RECORD AND THE INTRAOCULAR LENS IS ADDED AS A CONCOMITANT PRODUCT FOR THE CARTRIDGE PRODUCT. THIS FOLLOW-UP #1 REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA UNDER MFR REPORT NUMBER 3012236936-2024-0002829. SEPARATE REPORT IS SUBMITTED FOR THE INTRAOCULAR LENS PRODUCT RECORD. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. SECTION D4: LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: REPORTER: MIDDLE NAME: UNKNOWN/ NOT PROVIDED. SECTION E1: REPORTER: EMAIL ADDRESS: UNKNOWN/ NOT PROVIDED. SECTION E1: REPORTER: ADDRESS: ADDRESS - LINE 2: UNKNOWN/ NOT PROVIDED. SECTION E1: REPORTER: ADDRESS: STATE, PROVINCE, OR TERRITORY: UNKNOWN/ NOT PROVIDED. SECTION E1: REPORTER: POST OFFICE OR ZIP CODE: UNKNOWN/ NOT PROVIDED. SECTION E1: REPORTER: TELEPHONE NUMBER: (B)(6). SECTION H3: 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 WHEN DOCTOR DID THE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) INSERTION, THERE WAS RESISTANCE, WHEN PUSHED IN EYE, THERE WAS A DEFECT AT THE HAPTIC OPTIC JUNCTION, THEREFORE DOCTOR REMOVED THE IOL IN SAME PROCEDURE AND REPLACED IT WITH BACKUP IOL. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT BELONGS TO CARTRIDGE. ANOTHER REPORT IS SUBMITTED FOR INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972329 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male ZCB00 (SERIAL NUMBER: (B)(6)).