BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 4811709 · Received June 2, 2015

    Report

    Report Number
    2648035-2015-00332
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 5, 2015
    Report Date
    September 1, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: AGE: THE PATIENT'S AGE HAS BEEN CORRECTED TO (B)(6) YEARS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EXPLANTED DATE: NOT APPLICABLE; DEVICE STILL IMPLANTED. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW WAS PERFORMED. ALL PROCESS OPERATIONS DOCUMENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS AND SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS DISPOSITION. NO NON-CONFORMANCE REPORT (NCR) WAS GENERATED DURING THE MANUFACTURING PROCESS OF THIS LOT. A REVIEW OF THE RAW MATERIAL/MANUFACTURING PROCEDURES IN THE CHANGE CONTROL SYSTEM WAS DONE DURING THE PERIOD WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS THAT COULD BE RELATED WITH THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (B)(4). AGE AT TIME OF EVENT - (B)(6) YEARS, DATE OF BIRTH: (B)(6). THE INTRAOCULAR LENS (IOL) WAS RETURNED TO MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE IOL IS CUT IN HALF AND WITH ONE (1) LENS HAPTIC DETACHED. DUE TO THE DAMAGED CONDITION OF THE RETURNED LENS ADDITIONAL EVALUATION CANNOT BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AFTER IMPLANTING A SENSAR INTRAOCULAR LENS (IOL) THE HAPTIC DETACHED FROM THE OPTIC. THE HAPTIC DID NOT BREAK, IT DETACHED AT THE HAPTIC-OPTIC JUNCTION. VISUAL ACUITY PRE-OPERATIVELY WAS 20/40 AND AFTER SURGERY IT WAS 20/50. THE PATIENT EXPERIENCED BLURRED VISION IN THE TEMPORAL FIELD OF VISION DUE TO THE LENS BEING DISLOCATED. IN FOLLOW UP IT WAS LEARNED THE SURGEON WAS ABLE TO REMOVE THE DETACHED HAPTIC DURING THE SURGERY. A REPLACEMENT LENS WAS NOT IMPLANTED DURING THE PROCEDURE AS THE PATIENT HAD A PANIC ATTACK AND DID NOT WANT TO STAY MORE TIME. A SECONDARY PROCEDURE TO EXPLANT THE LENS IS PLANNED BUT HAD NOT YET BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357094 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention