BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 2936255 · Received January 30, 2013

    Report

    Report Number
    2648035-2013-00067
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT ONE (1) OF THE HAPTIC LEGS WAS TRAPPED BETWEEN THE CARTRIDGE AND THE PISTON AS THE LATTER WAS PULLED OUT. AFTER NUMEROUS ATTEMPTS TO PUSH IT BACK INTO THE EYE, THE LEG FINALLY BROKE AT ITS JUNCTION WITH THE OPTIC PART OF THE INTRAOCULAR LENS (IOL). THE IOL HAD TO BE CUT AND EXTRACTED AND A NEW IOL WAS IMPLANTED SUCCESSFULLY. PATIENT WAS TREATED WITH STANDARD POST-OPERATIVE CARE: DEXAMETHASONE EYE DROPS (1MG/ML) THREE TIMES A DAY FOR 3 WEEKS. POST-OPERATIVE STATUS: UNCOMPLICATED. VISUAL ACUITY 20/20 ADD (-0.50 CYL X 190) NO FURTHER INFORMATION WAS PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS AT THE DIOPTER INSPECTION OPERATION, LENSES WERE MEASURED 100% FOR DIOPTER POWER, RESOLUTION, AND ASTIGMATISM. THE DOCUMENTATION FOR THE DIOPTER POWER INSPECTION PROCESS WAS REVIEWED AND FOUND WITHIN SPECIFICATION. ALL LENSES WERE INSPECTED FOR HAPTIC THICKNESS, HAPTIC WIDTH, AND OPTIC DIAMETER. NO DEVIATIONS WERE REPORTED, ALL LENSES HAD ACCEPTABLE HAPTIC WIDTH AND THICKNESS. AT THE FINAL INSPECTION PROCESS, THE LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION INCLUDING SURFACES RESIDUALS. THESE ACTIVITIES WERE PERFORMED UNDER LAMINAR FLOW HOOD. NO ISSUES WERE REPORTED. ALL UNITS MANUFACTURED WERE 100% VISUALLY INSPECTED AND NO DEVIATIONS RELATED TO CARTRIDGES WERE REPORTED. NO DEVIATIONS RELATED TO THE PRELOADED INSERTER (HANDPIECE) WERE REPORTED. THE LUBRICITY TESTS PERFORMED WERE FOUND WITHIN SPECIFICATIONS. NO DEVIATIONS RELATED TO THE CARTRIDGE CONDITIONS WERE REPORTED. ALL PROCESS OPERATIONS WERE FOUND IN COMPLIANCE. THE MANUFACTURING RECORDS AND RELATED DOCUMENTS SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRELOADED INSERTION SYSTEM AND INTRAOCULAR LENS WERE RETURNED TO THE MANUFACTURER. VISUAL INSPECTION REVEALED THAT THE CARTRIDGE HAD SMALL AMOUNT OF VISCOELASTIC DRIED SOLUTION IN THE CARTRIDGE. THE SAMPLE WAS RECEIVED IN CUT INTO TWO HALVES. ALSO, ONE HALF OF THE LENS WAS RECEIVED WITHOUT HAPTIC. THIS IS CONDITION IS TYPICAL FOR AN INTRAOCULAR LENS THAT HAS BEEN CUT IN HALF TO BE EXPLANTED. DIRECTIONS FOR USE (DFU) STATES THAT USER SHOULD "INSERT THE OPTHALMIC VISCOSURGICAL DEVICE (OVD) CANULA INTO THE TIP OF THE PROTECTIVE CAP. COMPLETELY FILL THE VIEWING WINDOW WITH OVD." CONCLUSION: CONDITION OF DETACHED HAPTIC WAS VERIFIED IN THE SAMPLE RETURNED. EVIDENCE FOUND IN THE SAMPLE DEMONSTRATES THAT SAMPLE WAS NOT USED ACCORDING TO THE DFU INSTRUCTIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS DEVICE IS NOT APPROVED BY THE FDA; HOWEVER, IT IS A SAME/SIMILAR DEVICE AS MODEL ZCB00-PMA P980040. PRIOR TO RELEASE TO MARKET, THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) HAPTIC FOLLOWED THE INJECTOR PISTON BACK INTO THE INJECTOR AFTER THE SEVERAL ATTEMPTS AT IMPLANTATION OF THE INTRAOCULAR LENS, (IOL) INTO THE PATIENT'S EYE. THE HAPTIC DETACHED FROM THE IOL AND WAS REMOVED FROM THE PATIENT'S EYE BY DIVIDING (CUTTING) IT. ANOTHER NON PRELOAD LENS, THE SAME TYPE, WAS IMPLANTED INTO THE PATIENT'S EYE WITH NO FURTHER REPORTED PROBLEMS. UNNECESSARY SUFFERING ALONG WITH POSSIBLY IMPAIRED VISION WERE REPORTED BY THE DOCTOR. TRAINING ON THE PRELOADED LENS WAS PROVIDED TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40104 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention