BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE MINITURE TELESCOPE

    MDR report key: 2577663 · Received May 7, 2012

    Report

    Report Number
    3005347768-2012-00001
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 10, 2012
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES,LTD.
    Product Code
    NCJ
    PMA / PMN Number
    P050034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON STATED THAT THE ADVERSE EVENT IS NOT SUSPECTED AS DEVICE RELATED IN ORIGIN AND IS ATTRIBUTED TO THE PATIENT'S NONCOMPLIANCE WITH POSTOPERATIVE INSTRUCTIONS (EYE RUBBING). THE DEVICE LABELING AND PATIENT INFORMATION LABELING CLEARLY CAUTIONS AGAINST EYE RUBBING POSTOPERATIVELY AND IS CONTRAINDICATED IN PATIENTS WHO RUB THEIR EYES CHRONICALLY. TWO OTHER IMPLANT DEVICES FROM THE SAME BATCH WERE IMPLANTED AT THE SAME USER FACILITY ON THE SAME DAY AND NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THESE PATIENTS. THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED FOR THE BATCH OF THE DEVICE INVOLVED AND NO DEVIATIONS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6), 2012, A PATIENT UNDERWENT TELESCOPE IMPLANTATION FOR END-STAGE MACULAR DEGENERATION. ON THE DAY ONE POSTOPERATIVE EXAM, THE EYE WAS QUIET, CORNEA CLEAR, AND INTRAOCULAR PRESSURE WAS 27 MMHG. AT THE ONE-WEEK POSTOPERATIVE VISIT ((B)(6), 2012), THE PATIENT PRESENTED WITH SUSPECTED ENDOPHTHALMITIS IN THE OPERATIVE EYE. THE EYE WAS RED/PUFFY, HAD A FLAT ANTERIOR CHAMBER, AND THE IRIS HAD PROLAPSED. AT THIS VISIT, A CORE VITRECTOMY WAS PERFORMED, THE ANTERIOR CHAMBER WAS RE-ESTABLISHED, AND THE IRIS PROLAPSE WAS CORRECTED. A CULTURE WAS TAKEN TO IDENTIFY THE CAUSE OF THE INFECTION AND THE PATIENT'S MEDICATION REGIMEN WAS ADJUSTED. THE RETINA SPECIALIST WHO CONDUCTED THE INTERVENTIONS DESCRIBED ABOVE REPORTED THAT THE TELESCOPE REMAINS IN-SITU, WAS WELL-POSITIONED, AND IN AN INTACT CAPSULAR BAG. THE RETINA SPECIALIST SUSPECTED THAT THE CAUSE OF THE FLAT ANTERIOR CHAMBER, IRIS PROLAPSE, AND ENDOPHTHALMITIS WAS ATTRIBUTED TO THE PATIENT'S POSTOPERATIVE EYE RUBBING. THE PHYSICIAN QUESTIONED THE PATIENT AND THE PATIENT'S FAMILY MEMBER ABOUT EYE RUBBING. BOTH VERIFIED THE PATIENT WAS RUBBING THE EYE, INCLUDING LIFTING THE EYE SHIELD THAT WAS PROVIDED FOR PROTECTION AFTER SURGERY. THE PATIENT'S FAMILY MEMBER ALSO INDICATED THEY HAD ADVISED THE PATIENT TO NOT RUB THE EYE. THE PHYSICIAN STATED "THE EVENT IS NOT DEVICE RELATED." IN A FOLLOW-UP CALL ON (B)(6), 2012 WITH THE RETINA SPECIALIST, HE REPORTED THE PATIENT'S CONDITION AS GUARDED AND STABLE. THE PATIENT HAS BEEN PLACED ON AN APPROPRIATE REGIMEN OF ANTIBIOTICS AND STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE MINITURE TELESCOPE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES,LTD. WA 2.7X 10603

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention