BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3200612 · Received July 1, 2013

    Report

    Report Number
    9614546-2013-00107
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURING RECORD REVIEW, ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TEST RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATIONS OR NON-CONFORMANCES (NCR) WERE GENERATED DURING MANUFACTURING. THE LENS DIOPTER RESULT OBTAINED FROM THE MIQ (MEASUREMENT IOL QUALITY) ELECTRONIC SYSTEM OF THE TEST PERFORMED WHEN THIS LENS WAS MANUFACTURED, SHOWS THAT LENS SERIAL NUMBER CORRESPONDED TO THE CORRECT DIOPTER POWER. NO DEVIATION WAS REPORTED. BASED ON THE DOCUMENTS REVIEWED (LINE CLEARANCE ACTIVITIES AT MIQ, FIRST PACK), THERE IS NO DEVIATION OR ANY NON-CONFORMITY THROUGHOUT THE PROCESS. THE INFORMATION DOCUMENTED DOES NOT SUPPORT ANY POTENTIAL MIX UP DURING MANUFACTURING PROCESS. A REVIEW OF THE RAW MATERIAL/MANUFACTURING PROCEDURES WAS DONE AND DID NOT SHOW ANY CHANGE IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS THAT WERE RELATED TO THE COMPLAINT. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA THE EXPLANTED INTRAOCULAR LENS (IOL) WAS REPLACED WITH ONE OF A LOWER DIPTER OF THE SAME MODEL. THE INITIAL REPORT INDICATED THERE WAS NO QUALITY ISSUE WITH THE EXPLANTED IOL. PATIENT HAD PREVIOUS LASIK PROCEDURE. CONCLUSION: FURTHER EXPLANATION: THE IOL WAS RETURNED TO THE MANUFACTURER UNDER A RETURNED GOODS AUTHORIZATION THAT DID NOT INDICATE THERE HAD BEEN AN EXPLANT. THEREFORE, IT WAS DESTROYED AND NOT SUBMITTED FOR INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE INTRAOCULAR LENS APPROXIMATELY THREE (3) WEEKS POST OPERATIVELY DUE TO A REFRACTIVE ERROR. THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298047 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention