BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO IA TIP, STRAIGHT, .3MM

    MDR report key: 7111023 · Received December 12, 2017

    Report

    Report Number
    3006695864-2017-01314
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 14, 2017
    Report Date
    April 14, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    UDI-DI
    05050474521070
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO THE SPECIFICATIONS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER TELEPHONE: (B)(6). DEVICE MANUFACTURER YEAR 2017. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FSS FOUND NO ISSUES WITH THE OPERATION OF THE EQUIPMENT. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, A HOSPITAL REPORTED THE POSTERIOR CHAMBER RUPTURED DURING THE IRRIGATION AND ASPIRATION SEGMENT. THE HOSPITAL INDICATED THE IOL WAS IMPLANTED OUTSIDE THE CAPSULAR BAG AS THE POSTERIOR CAPSULE SPLIT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROBLEMS. THE HOSPITAL REQUESTED TO CHECK AND ADJUST THE VACUUM PRESSURE AND CHECK THE CONDITION OF THE TIP OF I/A. THIS REPORT IS FOR THE IRRIGATION/ASPIRATION (I/A TIP). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888445 SOLO IA TIP, STRAIGHT, .3MM PHACO ACCESSORY HQC ABBOTT MEDICAL OPTICS OPO1A20STR 081555 05050474521070

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other