BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 5097448 · Received September 23, 2015

    Report

    Report Number
    9614546-2015-00259
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    July 8, 2015
    Report Date
    November 23, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURN SAMPLE WAS VISUALLY INSPECTED UNDER A MICROSCOPE. IT CAN BE SEEN THAT THE LENS WAS RECEIVED CUT IN HALF. THE LENS CONDITION IS CONSISTENT OF A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. DUE TO THE CONDITION OF THE LENS, NO FURTHER ANALYSIS WAS POSSIBLE. A REVIEW OF THE DIRECTIONS FOR USE (DFU) WAS CONDUCTED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE MANUFACTURING RECORD REVIEW WAS PERFORMED. NO NON CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE IN-LINE OPTICAL INSPECTION DATA SHOWS THE LENS IS WITHIN POWER SPECIFICATION. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLANT OF AN INTRAOCULAR LENS (IOL) IN A SECONDARY PROCEDURE FROM BOTH EYES. IT WAS STATED THAT THE PATIENT DID NOT HAVE DESIRED OUTCOME ACHIEVED; THEREFORE ASKED FOR THE LENS TO BE REMOVED. THE NEW LENS WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING FACILITY THAT AFTER IMPLANTATION OF THE IOL, THE PATIENT COMPLAINED OF FLASHES POST-OPERATIVELY ON (B)(6) 2015. ON (B)(6) 2015, PATIENT HAD DEPTH PERCEPTION ISSUES. THEN ON (B)(6) 2015, PATIENT HAD PROBLEM WITH FOCAL LENGTH WORKING IN THE SHOP. ON (B)(6) 2015, THE PATIENT COMPLAINS OF GLARE/HALOS, SPIKES. PATIENT CAN'T DRIVE AT NIGHT, GLARE IN DAYLIGHT, AS WELL AS CAN'T SEE THE PASTOR IN CHURCH UNDER THE CEILING LIGHTS. TRACE POSTERIOR CAPSULAR OPACIFICATION (PCO) RIGHT EYE (OD), 1+ PCO LEFT EYE (OS) VISUAL ACUITY SANS CORRECTION (VASC) OD 20/60 OS 20/50. A MODEL ZLB00 LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2015 AND EXPLANTED ON (B)(6) 2015. A MODEL ZKB00 LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015 AND EXPLANTED ON (B)(6) 2015. PATIENT HAD A POST-OPERATIVE APPOINTMENT ON (B)(6) 2015, PATIENT REPORTS INDICATED THAT THE VISUAL ACUITY FOR THE LEFT EYE (OS) HAS BEEN ''DRASTICALLY'' IMPROVED. PATIENT ALSO HAD ANOTHER POST-OPERATIVELY APPOINTMENT ON (B)(6) 2015, PATIENT'S VISUAL PHENOMENA HAS BEEN RESOLVED. VISUAL ACUITY SANS CORRECTION (VASC) FOR THE RIGHT EYE SHOWED 20/30-2 AND FOR LEFT EYE 20/25. REPORTEDLY, THERE WAS NO PATIENT INJURY. NOTE: A SEPARATE MEDWATCH REPORT IS BEING SUBMITTED FOR EACH EYE. THIS REPORT IS FOR SERIAL NUMBER (B)(4) FOR THE LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627947 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention