BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3778860 · Received April 29, 2014

    Report

    Report Number
    2648035-2014-00206
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: VISCOELASTIC DURING SURGERY: DUOVISC ALCON. IRRIGATING SOLUTION & MEDICATION DURING SURGERY: SERUM PHY BSS. (B)(6). (B)(4). REASON FOR NON EVALUATION: CODE 81 - TO DATE, THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    HOSPITALIZATION SHOULD HAVE BEEN CHECKED. CONCOMITANT PRODUCTS: 1MTEC30 CARTRIDGE, LOT CM01962, DUO VISC (ALCON) AND BALANCED SALT SOLUTION (SERUM PHY) MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS (IOL) WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE (NCR) WAS REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POST OPERATIVE FOLLOW UP VISIT AT SEVEN (7) DAYS WAS OK AND THEN PATIENT CAME BACK ONE (1) DAY LATER AND SHOWED A VISION LOSS WITHIN 24 HOURS WITHOUT RED EYE NOR PAIN. PATIENT WAS HOSPITALIZED FOR PUNCTURE OF ANTERIOR CHAMBER AND INTRA VITREOUS TREATMENT AND IV ANTIBIOTICS. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. POST OPERATIVE HISTORY, INCLUDING POST-OP VISUAL ACUITIES AT DAY 7 WAS 4/10, MYOPY AT -15 WITH CATARACT. ON (B)(4) 2014, PATIENT WAS OK WITH A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256644 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 1MTEC30 INSERTER LOT CM01962DUO VISC (ALCON)