BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4090576 · Received September 15, 2014

    Report

    Report Number
    2648035-2014-00481
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AHS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6). PATIENT HAD LOOSE XONULES. THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED AND THE LENS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE VISUAL INSPECTION REVEALED THAT THE LENS HAD VISCOELASTIC RESIDUE, SURFACE SCRATCHES, SURFACE RESIDUALS (FIBER/PARTICLES) AND A CRACK IN THE OPTIC ZONE. BASED ON THE INVESTIGATION, THERE WERE NO COSMETIC DEFECTS RELATED TO MANUFACTURING PROCESS FOUND IN THE RETURNED LENS. THE INVESTIGATION FINDINGS ARE MOST LIKELY THE RESULT OF THE EXPLANT PROCESS AND HAVE BEEN IDENTIFIED AS OPERATIONAL IN THE RESULTS CODE. THE LENS WAS RECEIVED IN A CONDITION WHICH PROHIBITED FURTHER ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS WERE IN COMPLIANCE WITH MANUFACTURING PROCEDURE SPECIFICATIONS. NO DEVIATION OR NON-CONFORMANCE WAS FOUND RELATED TO THE REPORTED COMPLAINT. THERE WERE NO DISCREPANCIES OR DEFECTS FOUND DURING THE REVIEW RELATED TO POSSIBLE CAUSES IDENTIFIED FOR THE REPORTED COMPLAINT. THE DOCUMENTATION SHOWED THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED IN THE SAME PROCEDURE IN THE LEFT EYE OF THE PATIENT OWING TO THE FACT THAT THE CAPSULAR BAG COLLAPSED DUE TO LOOSE ZONULES AND THE LENS HAD TO BE REMOVED AND REPLACED. THERE WAS NO INCISION ENLARGEMENT PERFORMED TO EXPLANT THE LENS .THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570468 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention