BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 3100842 · Received May 8, 2013

    Report

    Report Number
    2648035-2013-00210
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE INTRAOCULAR LENS (IOL) THAT THE DOCTOR HAD TO FREE THE HAPTICS AS THE IRRIGATION/ASPIRATION (I/A) WAS NOT WORKING AND THE DOCTOR HAD TO TAKE A HOOK TO UNSTICK THE HAPTICS. THE CAPSULAR BAG WAS WEAK AND THREATENED TO COLLAPSE. THE LENS WAS IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED AND ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO EVENT WERE REPORTED. THE MANUFACTURING RECORDS AND RELATED DOCUMENTS SHOW THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INTRAOCULAR LENS REMAINS IMPLANTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    NO. 2 OF MDR NO. 2648035-2013-00210 WAS CREATED AND SUBMITTED TO THE FDA IN ERROR. THE INFORMATION HAS ALREADY BEEN SUBMITTED TO THE FDA ON FOLLOW-UP NO. 1 MDR NO. 2648035-2013-00210 ON (B)(6) 2013. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE INTRAOCULAR LENS (IOL) THAT THE DOCTOR HAD TO FREE THE HAPTICS AS THE IRRIGATION/ASPIRATION (I/A) WAS NOT WORKING AND THE DOCTOR HAD TO TAKE A HOOK TO UNSTICK THE HAPTICS. THE CAPSULAR BAG WAS WEAK AND THREATENED TO COLLAPSE. THE LENS WAS IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED AND ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO EVENT WERE REPORTED. THE MANUFACTURING RECORDS AND RELATED DOCUMENTS SHOW THAT 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 DURING IMPLANT OF THE INTRAOCULAR LENS (IOL) THAT THE DOCTOR HAD TO FREE THE HAPTICS AS THE IRRIGATION/ASPIRATION (I/A) WAS NOT WORKING AND THE DOCTOR HAD TO TAKE A HOOK TO UNSTICK THE HAPTICS. TWO (2) CAPSULAR BAGS WERE WEAK AND WERE THREATENED TO COLLAPSE. THE LENS WAS IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201399 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other