BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 5931566 · Received September 7, 2016

    Report

    Report Number
    2648035-2016-01393
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474561830
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR PMA NUMBER P980040 WAS ENTERED. THIS FIELD SHOULD HAVE BEEN LEFT BLANK AS THE PCB00V IS AN INTERNATIONAL DEVICE WHICH IS NOT SOLD IN THE UNITED STATES HOWEVER IT IS SIMILAR TO A PCB00 LENS WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. THIS STATEMENT WAS CAPTURED IN SECTION H10 OF THE INITIAL MDR. DEVICE EVALUATION: THE LENS WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THERE WERE NO NON-CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THE LENSES WERE RELEASED ACCORDING TO SPECIFICATIONS. THE COMPLAINT HISTORY SEARCH REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, TO DATE THERE IS NO INDICATION THAT THE LENS HAS BEEN EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA (B)(4) . ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND TWO DAYS POST-OP, PUS WAS OBSERVED ON THE EYE TISSUE. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR TREATMENT AND THE PATIENT WAS IDENTIFIED AS HAVING ALLERGIC SYMPTOMS TO THE PLASTIC. THE PATIENT WAS PRESCRIBED STEROIDS AND THE SYMPTOMS WERE GETTING BETTER. THERE WAS NO HYPEREMIA AND THE PATIENT'S VISUAL ACUITY IS COUNTING FINGERS AND NOTED MAY BE GETTING BETTER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583882 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V 05050474561830

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R