BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3803281 · Received May 9, 2014

    Report

    Report Number
    2648035-2014-00221
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. VISUAL INSPECTION FOUND THE LENS WITH NO DAMAGE OBSERVED. THE LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION AND NO COSMETIC DEFECTS WERE DETECTED. A SMALL AMOUNT OF VISCOELASTIC (OVD) RESIDUE WAS OBSERVED ON THE LEADING HAPTIC AND LENS EDGE. LOOSE PARTICLES WERE OBSERVED ON THE LENS OPTIC BODY COMPATIBLE WITH HANDLING THE LENS. DIOPTER MEASUREMENT PASSED OPTICAL PROPERTIES, DIOPTER RESULT WAS 18.5. THE CONDITION OBSERVED IN THE LENS WAS CONSISTENT WITH ONE THAT HAD BEEN REMOVED FROM A PATIENT'S EYE. NO COSMETIC DEFECT IN THE LENS OPTIC WAS OBSERVED THAT WOULD AFFECT THE VISUAL CORRECTION IN A PATIENT EYE. THERE WAS NO EVIDENCE TO SUGGEST ANY FAULT ON THE LENS OR MANUFACTURE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REQUIRED TO BE EXPLANTED FROM THE RIGHT EYE OF A PATIENT IN A SECONDARY PROCEDURE OWING TO DYSPHOTOPSIA. A NEW LENS WAS IMPLANTED IN THE EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280500 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention