BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2884228 · Received December 21, 2012

    Report

    Report Number
    9614546-2012-00215
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE EYE. NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. DUE TO THE CONDITION OF THE RETURNED SAMPLE, THE DIOPTER MEASUREMENT COULD NOT BE PERFORMED. CONCLUSION: THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - INTRAOCULAR LENS EXPLANT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS INTRAOCULAR LENS WAS PERFORMED. THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS FOR THIS LENS WAS VERIFIED AND WAS SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF (B)(4) FOR THE LENS. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH THE INTRAOCULAR LENS (IOL) IMPLANT AFTER APPROXIMATELY TWO (2) MONTHS IMPLANT DURATION. THE DOCTOR DID NOT FIND ANYTHING WRONG WITH THE LENS. THE EXPLANT SURGERY WAS COMPLETED WITH NO ADVERSE EFFECT ON THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention