BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3112672 · Received May 14, 2013

    Report

    Report Number
    2648035-2013-00218
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THE REVIEW OF THE MANUFACTURING DOCUMENTATION AND TESTING WERE FOUND WITHIN PRODUCT SPECIFICATIONS. NO DEVIATIONS OR NON-CONFORMANCES (NCR) WERE GENERATED. BASED ON THE MANUFACTURING RECORD REVIEW, NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FAILED AND PATIENT INJURY SUSTAINED. HOWEVER, THERE WERE NO DETAILS PROVIDED AS TO THE FAILURE OF THE INTRAOCULAR LENS (IOL) AND PATIENT INJURY. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211854 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other