BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLRFLXC

    MDR report key: 1990045 · Received February 15, 2011

    Report

    Report Number
    2648035-2011-00015
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT BY THE SURGEON TO AN INDEPENDENT LABORATORY FOR ANALYSIS AND NOT RETURNED TO THE MANUFACTURER. PRIOR TO RELEASE THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THE REMAINING LENSES MANUFACTURED IN THIS LOT AND NO CONCLUSION CAN BE DRAWN AT THIS TIME. PRODUCTION RECORDS ARE BEING REVIEWED AT THE MANUFACTURING SITE. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THAT THE INSPECTIONS FOR THE AFFECTED PRODUCTION ORDER MET ALL SPECIFICATIONS. WITH THIS RECORD REVIEW AND THE CUSTOMER FEEDBACK, WE COULD NOT IDENTIFY ANY PROCESS DEVIATION. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE LABORATORY ANALYZING THE INTRAOCULAR LENS. A SUPPLEMENTAL REPORT WILL BE FILED AS NECESSARY IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT ON POST-OPERATIVE DAY ONE, THE INTRAOCULAR LENS WAS NOTED TO BE CLOUDY IN AREAS NOT IN CONTACT WITH THE ANTERIOR CAPSULE REMNANT, BUT WAS PARTIALLY CLEAR BELOW. CENTRAL AREA WAS CLOUDY. THE PATIENT COMPLAINED OF GLARE AND THE LENS WAS SUBSEQUENTLY EXPLANTED WITHOUT COMPLICATION ON A DATE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLRFLXC MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS CLRFLXC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention