BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3803612 · Received May 9, 2014

    Report

    Report Number
    2648035-2014-00224
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 24, 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

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. NO COSMETIC DEFECTS, SUCH AS SCRATCHES OR DEPRESSION MARKS WERE OBSERVED. SMALL RESIDUES OF VISCOELASTIC (OVD) WERE OBSERVED ON THE LENS SURFACE (OPTIC ZONE). ALSO, LOOSE PARTICLES WERE OBSERVED ON THE LENS OPTIC BODY. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. THE LENS PASSED THE LENS OPTICAL PROPERTIES TESTING. NO DEVIATION WAS DETECTED IN THE COMPLAINT LENS. THE MANUFACTURING RECORD REVIEW WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED DURING MANUFACTURING OF THIS PRODUCTION ORDER. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE PRODUCT MET RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORT: MDR FOLLOW-UP NUMBER 1 WITH THE INVESTIGATION RESULTS WAS SUBMITTED AS MDR FOLLOW-UP NUMBER 2 IN ERROR. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LEFT EYE OF A PATIENT IN A SECONDARY PROCEDURE OWING TO THE LENS COMING OUT OF PLACE AS THE PATIENT HAD PSEUDOEXFOLIATION SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281958 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention