BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 4093749 · Received September 16, 2014

    Report

    Report Number
    2648035-2014-00484
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 20, 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
    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

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED OF THE RETURNED LENS AND WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. LENS WAS RECEIVED CUT IN THREE (3) PIECES. THE RECEIVED CONDITION WAS CONSISTENT WITH A LENS THAT HAS BEEN IMPLANTED AND EXPLANTED FROM THE PATIENT'S EYE. SURFACE RESIDUALS WERE ADHERED TO BOTH SIDES OF THE OPTIC BODY COMPATIBLE WITH HANDLING THE LENS. BASED ON THE INVESTIGATION, THE LENS CONDITION OBSERVED COULD BE ASSOCIATED TO A LENS THAT HAD BEEN EXPLANTED AND OPERATIONAL WAS CHOSEN FOR RESULTS CODE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM PRODUCT GENERATION TO PRODUCT BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. SLIT LAMP INSPECTION OF SILICONE LENS SHOWED THAT ALL THE LENSES SAMPLED HAD AN ACCEPTABLE HAZE LEVEL. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. 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 THE PATIENT IN A SECONDARY PROCEDURE BECAUSE THE PATIENT REPORTED ASTIGMATISM POST OPERATIVELY. THE SURGEON EXPLANTED THE Z9002 LENS AND EXCHANGED FOR ZCT150 22.5 DIOPTER LENS. THERE WAS NO 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
    573136 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention