BEUDAMED
    FDA Adverse Event Summary report: N

    TECNIS

    MDR report key: 2211044 · Received August 13, 2011

    Report

    Report Number
    2648035-2011-00168
    Date Received
    August 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RECEIVED FOR ANALYSIS. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. OUR INVESTIGATION INTO THIS EVENT IS INCONCLUSIVE. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LENS NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED LENS WAS CONDUCTED USING A MICROSCOPE UNDER 10X MAGNIFICATION. VISUAL EXAMINATION FOUND THAT THE OPTIC OF THE LENS IS CRACKED AT THE TOP OF THE LOOP (HAPTIC) AND ONE OF THE LOOPS (HAPTICS) IS DETACHED. REVIEW OF MANUFACTURING PROCESSES AND CONTROLS FINDS THAT THE LENS IS VISUALIZED UNDER 10X MAGNIFICATION TO INSPECT FOR (B)(4) STANDARDS FOR PROPER LOOP (HAPTIC) ATTACHMENT. PRIOR TO RELEASE, THIS DEVICE MET OUR SPECIFICATIONS. FURTHER INFORMATION PROVIDED BY THE SURGEON INDICATED THAT WHILE REMOVING THIS LENS FROM THE PATIENTS EYE, THE LOOP REPORTEDLY CAME OFF BECAUSE IT WAS BEING PULLED. IT IS THEREFORE UNDERSTOOD THAT THE LENS DID NOT PRESENT THIS CONDITION PRIOR TO THE INSERTION PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND / OR CONCLUSION OF THIS REPORT ANOTHER SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON OBSERVED A CRACK ON THE REAR HAPTIC OF THE INTRAOCULAR LENS AFTER IMPLANT. AS THE LENS WAS BEING REMOVED FROM THE PATIENT'S EYE, THE HAPTIC CAME OFF AS IT WAS BEING PULLED. THE MANUFACTURER WAS NOT ABLE TO CONFIRM IF THE INCISION WAS ENLARGED TO REMOVE THE LENS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention