BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 2905693 · Received January 9, 2013

    Report

    Report Number
    2648035-2013-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Removal / Correction Number
    2648035-01-03-13-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM IS BEING CORRECTED: BOTH ADVERSE EVENT AND PRODUCT PROBLEM ARE BEING REPORTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE RECALLED LENS WAS EXPLANTED ON (B)(6) 2012 AND REPLACED WITH THE CORRECT LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRIMARY CAUSE FOR THIS EVENT WAS THE INADVERTENT SWITCHING OF THE DEVICE HISTORY RECORD (DHR) LABELING POUCHES BETWEEN THE TWO TOTES OF THE IMPACTED LENSES ON AN IN-PROCESS STORAGE RACK.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE SHOULD HAVE BEEN INITIALLY INDICATED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED AND THE APPROPRIATE SECTIONS HAVE BEEN COMPLETED. AGE/DATE: (B)(6). SEX: FEMALE. (B)(4). ADDITIONAL INFORMATION RECEIVED STATED THE AFFECTED EYE IS THE RIGHT EYE AND POST IMPLANT OF THE AR40E IOL THE PATIENT EXPERIENCED BLURRED VISION, CHRONIC HEADACHES ON A DAILY BASIS AND INCREASED FATIGUE. THE IOL WAS EXPLANTED ON (B)(6) 2012. IN ORDER TO REMOVE THE LENS THE SURGEON WAS REQUIRED TO MAKE A LARGER CUT AND SUTURING WAS REQUIRED. POST EXPLANT THE PATIENT EXPERIENCED SORENESS, GRITTINESS, PHOTOPHOBIA AND STINGING WHEN DROPS WERE INSTILLED. ALSO THE PATIENT EXPERIENCED CORNEA MACRO-EROSION AND RIGHT PSEUDOPHAKIA. A LOOSE SUTURE WAS IDENTIFIED TO CLOSE THE EROSION. THE SUTURE WAS REMOVED AND INFLAMMATION WAS IDENTIFIED INSIDE THE ANTERIOR CHAMBER. THE PATIENT WAS FURTHER TREATED WITH ANTIBIOTIC AND STEROID DROPS. PATIENT EXPERIENCED A SLOW RECOVERY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HAVING ''PROBLEMS'' WITH THEIR VISION AFTER BEING IMPLANTED WITH AN INTRAOCULAR LENS (IOL). THE REPORT INDICATES THAT THE PATIENT COULD HAVE THEIR SURGERY RECTIFIED ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10423 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention