BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR ACRYLIC IOL

    MDR report key: 2052387 · Received April 12, 2011

    Report

    Report Number
    2648035-2011-00064
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 12, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040/R003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INTRAOCULAR LENS WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE INVESTIGATION INTO THIS REPORTED ADVERSE EVENT IS ONGOING AT THE MANUFACTURING SITE, RESULTS ARE INCONCLUSIVE AT THIS TIME. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS MANUFACTURING LOT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE SURGEON HAS DECLINED TO RETURN THE EXPLANTED INTRAOCULAR LENS (IOL) TO THE MANUFACTURER FOR ANALYSIS LIMITING THE SCOPE OF OUR INVESTIGATION. BATCH RECORDS ASSOCIATED WITH THE MANUFACTURING OF THIS LENS WERE REVIEWED AND SHOWED NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO OTHER COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. IN SUMMARY THE PRODUCT MET ALL RELEASE CRITERIA. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE VERIFIED, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT COMPLAINED OF POOR VISION ONE WEEK POSTOPERATIVE IMPLANT OF THE INTRAOCULAR LENS AND HAD A SUBJECTIVE REFRACTION OF +9 DIOPTER. THE INCISION WAS ENLARGED TO REMOVE THE INITIAL IMPLANT AND SUTURES PLACED TO CLOSE. VISION AT LAST FOLLOW-UP WAS 6/12 WITH 1.5 DIOPTER CYLINDER. PATIENT'S OUTCOME IS UNKNOWN AT THIS TIME. THE SURGEON DID NOT RETURN THE LENS TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSAR ACRYLIC IOL MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention