BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACN-60A

    MDR report key: 730308 · Received June 20, 2005

    Report

    Report Number
    2027748-2005-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2005
    Date of Event
    May 3, 2005
    Report Date
    June 8, 2005
    Manufacturer
    OPHTHALMIC INNOVATIONS INTERNATIONAL, INC.
    Product Code
    HQL
    Removal / Correction Number
    Z-869/871-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATHE ACN-60A WAS PART OF RECALL NUMBER Z-869 / 871-0

    Description of Event or Problem · 1

    OII'S CUSTOMER SERVICE RECEIVED AN EMAIL FROM AN OPHTHALMOLOGIST STATING THAT HE IS TREATING A PATIENT WHO WAS IMPLANTED BILATERALLY WITH OII'S PHAKIC IOLS BY A SURGEON. THE PATIENT IS CONCERNED THAT SHE HAS BAD IMPLANTS OR THAT THEY WERE NOT PUT IN PROPERLY. OII'S PRESIDENT RESPONDED TO THE OPHTHALMOLOGIST'S EMAIL AND ASKED FOR ENDOTHELIAL CELL COUNTS. ON 13 MAY 2005 OII RECEIVED A RESPONSE FROM THE OPHTHALMOLOGIST. THE CELL COUNT IS LOW. OD IS 741 AND THE OS IS 618. OII IS ATTEMPTING TO WORK WITH THE OPHTHALMOLOGIST ON FUTURE CARE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACN-60A ANTERIOR CHAMBER PHAKIC IOL HQL OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. ACN-60A 960315

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention