BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT MEDICALS OPTICS

    MDR report key: 3370420 · Received September 16, 2013

    Report

    Report Number
    2027748-2013-00001
    Event Type
    Injury
    Date Received
    September 16, 2013
    Date of Event
    July 25, 2013
    Report Date
    September 11, 2013
    Manufacturer
    AAREN SCIENTIFIC INC
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS IMPLANTED IN (B)(6) 2012. REFRACTIVE ERROR FOUND. REPORTED TO (B)(4) IN (B)(4) 2012. COMPLAINT CLASSIFIED AS "INVALID" DUE TO THE LACK OF INFO FROM THE CUSTOMER; COMPLAINT CLOSED 0(B)(4) 2012. LASIK SURGERY PERFORMED 07/2013. REPORTED TO (B)(4) IN (B)(4) 2013. COMPLAINT CLASSIFIED AS "INVALID" IN (B)(4) 2013. DOCTOR IMPLANTED LENS IN SULCUS, THIS LENS IS NOT INTENDED FOR CILIARY SULCUS PLACEMENT; LENS IS INTENDED FOR CAPSULAR BAG PLACEMENT ONLY. CUSTOMER USED LENS OFF LABEL RECOMMENDATIONS.

    Description of Event or Problem · 1

    ONE LENS WAS IMPLANTED WITH A REPORTED POST OPERATIVE ERROR OF -7.0. LASIK SURGERY WAS PERFORMED TO CORRECT VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464919 ABBOTT MEDICALS OPTICS INTRAOCULAR LENS HQL AAREN SCIENTIFIC INC SP-65A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention