BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2963910 · Received February 15, 2013

    Report

    Report Number
    2648035-2013-00090
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL SHOWED THE VITREOUS ASPIRATE WAS (B)(6) (USING POLYMERASE CHAIN REACTION). THERE WAS NO GROWTH ON CULTURE OF VITREOUS ASPIRATE. THE INFLAMMATORY RESPONSE STARTED 24 HOURS AFTER SURGERY AND WAS FULMINANT. THERE WAS NO RESPONSE TO INTRAVITREAL INJECTION OF VANCOMYCIN AND CEFTRAXONE. A COMPLETE VITRECTOMY WAS PERFORMED ON DAY 5 POST OPERATIVELY AT WHICH TIME THE RECOVERY WAS DRAMATIC. PIN HOLE VISUAL ACUITY ON (B)(6) 2013 WAS 20/20. IN THE DOCTOR'S OPINION, A TOXIC REACTION IS SUSPECTED. MANUFACTURING RECORD REVIEW: THE REVIEW OF THE DOCUMENTATION AND TESTING PRESENTED IN THE MANUFACTURING RECORD WERE FOUND WITHIN PRODUCT SPECIFICATIONS. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE WAS GENERATED. STERILIZATION RECORDS: THE STERILIZATION RECORD FOR THIS LOT WAS REVIEWED AND NO DEVIATION WAS FOUND DURING THE STERILIZATION CYCLE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MEMBRANE FORMATION. INTRAOCULAR LENS. TO DATE THE INTRAOCULAR LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SEX -FEMALE. DATE OF THIS REPORT-(B)(4) 2012. DATE RECEIVED BY MANUFACTURER-(B)(4) 2012. EXPIRATION DATE - 03/31/2016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF THE INTRAOCULAR LENS (IOL) ON (B)(6) 2013. ON POST OPERATIVE DAY 2, THE PATIENT HAD MEMBRANE FORMATION. THIS WAS THE PATIENT'S SECOND LENS EYE IMPLANT. THE PATIENT'S FIRST LENS EYE IMPLANT WAS ABSOLUTELY FINE. BOTH LENS IMPLANTS WERE THE SAME AMO MODEL LENS. A REPORTED VISION LOSS OCCURRED 2 DAYS AFTER SURGERY ((B)(6) 2013) AND THERE WERE MEMBRANES FORMED. ON THE POST OPERATIVE DAY THREE, (B)(6) 2013, THE VITREOUS CAVITY WAS FULL OF EXUBERATES AND WHITE HYPOPYON WAS OBSERVED. THERE WAS NO PAIN AND ONLY MILD REDNESS. A VITRECTOMY WAS PERFORMED ON (B)(6) 2013, WHERE SILICON OIL WAS INJECTED. POST OPERATIVELY, THERE WAS THICK WHITISH MEMBRANE THAT WAS MILD PINKISH IN APPEARANCE. THE DOCTOR REPORTED THERE WERE NO CHANGES OF VISCOELASTIC, O.R. INSTRUMENTS, ETC. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67849 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention