BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4090586 · Received September 15, 2014

    Report

    Report Number
    2648035-2014-00480
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT. INCISION ENLARGEMENT. PATIENT ASTIGMATISM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WHERE THE SAMPLE WAS RECEIVED CUT IN TWO (2) PARTS. LOOSE PARTICLES WERE OBSERVED ON THE SAMPLE COMPATIBLE WITH HANDLING THE LENS. THE SAMPLE WAS OBSERVED WITH THE CHARACTERISTIC OF SILICONE MATERIAL AND LENS PART HAD A FROSTED EDGE FOUND IN THE SILICONE LENS, MODEL Z9002. PER THE INITIAL REPORT, THERE WAS NO QUALITY ISSUE WITH THE LENS AND THE EXPLANT WAS DUE TO A PATIENT CONDITION OF ASTIGMATISM. BASED ON THE INVESTIGATION, THE LENS WAS NOT AFFECTED BY THE MANUFACTURING PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT DATE OF BIRTH AND GENDER HAVE ADDED. IT WAS REPORTED THAT PROCEDURE WAS DONE ON PATIENT'S RIGHT EYE. PATIENT OUTCOME WAS NOTED TO BE GOOD WITH A VISUAL ACUITY OF 20/25. ADDITIONALLY, IT WAS LEARNED THAT THE EXPLANT OF THE IOL WAS NOT DUE TO THE PERFORMANCE OR QUALITY OF THE LENS. IMPLANT DATE HAS BEEN ADDED. DEVICE EVALUATION: A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. A REVIEW OF THE MANUFACTURING PROCESS AND/OR MATERIALS SHOW THERE WERE NO CHANGES IN MANUFACTURING ASSOCIATED WITH THIS PRODUCTION ORDER. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS Z9002(IOL) WAS REQUIRED TO BE EXPLANTED FROM THE PATIENT'S EYE IN A SECONDARY PROCEDURE BECAUSE CUSTOMER USED ORA AND FOUND THAT THE PATIENT HAD TOO MUCH ASTIGMATISM AND HENCE REMOVED THE LENS AND REPLACED WITH AN ALCON TORIC LENS. THERE WAS INCISION ENLARGEMENT PERFORMED TO EXPLANT THE LENS .THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569589 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention