BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 2233500 · Received September 2, 2011

    Report

    Report Number
    2648035-2011-00195
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION WAS RECEIVED FROM THE REPORTER AND WE ARE CONTINUING OUR INVESTIGATION. PRODUCT SERIAL NUMBER WAS NOT IDENTIFIED, PRECLUDING A MANUFACTURING RECORD REVIEW. WE HAVE NO REASON TO SUSPECT THIS PRODUCT WAS DEFICIENT. THE LENS WAS IMPLANTED (B)(6) AGO AND ONLY RECENTLY DISLOCATED IN THE PATIENT'S EYE. THE DEFINITIVE CAUSE OF THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER. THE RESULTS OF OUR INVESTIGATION ARE INCONCLUSIVE AT THIS TIME. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS REPORTED TO THE MANUFACTURER WAS RECEIVED. VISUAL AND DIMENSIONAL INSPECTION OF THE DEVICE AT THE MANUFACTURING SITE CONFIRMS THE RETURNED LENS WAS NOT MANUFACTURED BY AMO AS PREVIOUSLY REPORTED. NO FURTHER INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD CATARACT SURGERY (B)(6) AGO, EXACT DATE UNKNOWN, WITH INTRAOCULAR LENS IMPLANT. ON A DATE UNKNOWN THE LENS PARTIALLY SUBLUXATED AND THE SURGEON REMOVED THE LENS. HE REPORTED THE HAPTIC WAS ATTACHED TO THE CAPSULE, IT WAS LEFT IN THE EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other