BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPASS SYSTEM

    MDR report key: 8865916 · Received August 6, 2019

    Report

    Report Number
    2523835-2019-00351
    Event Type
    Injury
    Date Received
    August 6, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    OGO
    PMA / PMN Number
    P150037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER HAS NOT PROVIDED SUFFICIENT CLINICAL DATA FOR EVALUATION WITH THIS COMPLAINT. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. PHOTOS PROVIDED WERE REVIEWED BY THE MANUFACTURING SITE. PHOTOS 1 AND 3 WERE OF THE PATIENT EYE AND PHOTO 2 AND 4 WERE OF A PARTIAL COMPUTER SCREEN, THE REPORTED ISSUES COULD NOT BE CONFIRMED FROM THE PHOTOS. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. BECAUSE SUFFICIENT CLINICAL DATA WAS NOT RECEIVED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. BASED ON THE PRELIMINARY INVESTIGATION FINDINGS, THERE HAS BEEN NO CHANGE IN CRITICALITY FOR THIS COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT IS EXPERIENCING DECOMPENSATION OF THEIR CORNEA AND ENDOTHELIAL CELL LOSS APPROXIMATELY ONE YEAR FOLLOWING IMPLANT OF A MICRO-FILTRATION DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660908 CYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other