BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4111576 · Received September 23, 2014

    Report

    Report Number
    2648035-2014-00496
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE AND BEST ESTIMATE DATE ARE NOT AVAILABLE. INFORMATION WAS ASKED BUT NOT PROVIDED (ASKU). IF EXPLANTED, GIVE DATE: NOT APPLICABLE (NA). LENS REMAINS IMPLANTED CURRENTLY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM PRODUCT MOLDING TO PRODUCT BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NONCONFORMANCE (NCR) WAS GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. ALSO, MANUFACTURING INSTRUCTIONS FOR THE SLIT LAMP PROCEDURE PROVIDES SPECIFIC INSTRUCTIONS FOR THE PREPARATION, INSPECTION (INCLUDING HAZE ACCEPTANCE CRITERIA) AND DISPOSITION OF SILICONE LENSES USING THE SLIT LAMP MICROSCOPE. THE REVIEW OF THE DOCUMENTATION FOR THE SLIT LAMP INSPECTION OF SILICONE LENS (INSPECTION) SHOWED THAT ALL THE LENSES SAMPLED HAD AN ACCEPTABLE HAZE LEVEL. THEREFORE NO DEVIATION WAS REPORTED FOR THE COMPLAINT TYPE ¿CLOUDY LENS¿, DURING THE MANUFACTURING OF THIS PRODUCTION ORDER. NO FURTHER INVESTIGATION IS REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE AMO SALE REPRESENTATIVE BY THE PHYSICIAN THAT PATIENT HAS BEEN EXPERIENCING OPACIFICATION (CLOUDINESS) OF THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE LEFT EYE. IT WAS NOTED THAT THE OPACIFICATION WAS FOUND TO BE WITHIN THE MATRIX OF THE LENS, AT THE POSTERIOR SURFACE, CAUSING POSTERIOR CAPSULE OPACIFICATION (PCO). ALSO, IT WAS FURTHER NOTED BY THE PHYSICIAN THAT PATIENT IS UNHAPPY WITH HIS VISUAL ACUITY AND VISUAL FUNCTION. THE POSSIBILITY OF THE LENS EXCHANGE HAS BEEN DISCUSSED, BUT THE PATIENT HAS OPEN POSTERIOR CAPSULE WHICH PRESENT SIGNIFICANT CHALLENGES. ADDITIONAL INFORMATION WAS PROVIDED INDICATING IMPLANT PROCEDURE WAS PERFORMED SUCCESSFULLY IN 2007 WITH NO PATIENT COMPLICATIONS AND THAT VITRECTOMY WAS PERFORMED AT A LATER DATE, SPECIFIC EYE WAS NOT IDENTIFIED. PROCEDURE DETAILS WERE ASKED BUT NOT PROVIDED. PATIENT WAS SEEN IN A RECENT EXAMINATION AND WAS PRESCRIBED GLASSES. THE ONSET OF VISUAL ISSUES WAS ASKED HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS BEEN REFERRED TO A SPECIALIST TO PURSUE EXPLANTATION OF IOLS. NO FURTHER INFORMATION HAS BEEN PROVIDED. COMPANION EYE WILL BE SUBMITTED IN A SEPARATE MDR SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591404 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention