BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE PACK

    MDR report key: 21876493 · Received April 21, 2025

    Report

    Report Number
    3007069947-2025-00001
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 23, 2025
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OJK
    UDI-DI
    00191072211514
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT LOT DEVICE HISTORY RECORD WAS REVIEWED, NO ISSUES WERE FOUND. SITE DETERMINED WAREHOUSE STORAGE CONDITIONS MAY HAVE CONTRIBUTED TO THE OBSERVED ISSUE AS THESE LABELS WERE BEING STORED IN A WAREHOUSE AREA WITH MINIMAL CLIMATE CONTROL. THE STORAGE LOCATION HAS BEEN UPDATED TO A CONTROLLED ENVIRONMENT. A QUALITY ALERT WAS INITIATED AND REVIEWED WITH TEAMMATES AND MANAGEMENT. EACH CASE OF WHITE LABELS IS TESTED PRIOR TO USE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). . THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (B)(4). . THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER STATES MULTIPLE PIECES OF BLACK MATERIAL, POSSIBLY INK, WAS COMING OFF LABELS ONTO SURGEON'S GLOVES DURING AN IMPLANT PROCEDURE. THE PRODUCT WAS USED DURING IOL IMPLANT PROCEDURE AND WAS NOT NOTICED UNTIL DEBRIS WAS SEEN IN THE EYE BY THE SURGEON. THE DEBRIS WAS REMOVED FROM PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911530 EYE PACK EYE PACK OJK AMERICAN CONTRACT SYSTEMS CMEY17 42-8082511 00191072211514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other