FDA.reportPublic FDA data

MAUDE MDR 2577663

MDR report key
2577663
Report number
3005347768-2012-00001
Event key
0
Event type
3
Date of event
2012-04-09
Date received
2012-05-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BORIS ARADOVSKY
Address
21 YEGIA KAPAYIM PETAH TIKVA 49130 IS
Phone
392-392-3928
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPLANTABLE MINITURE TELESCOPEVISIONCARE OPHTHALMIC TECHNOLOGIES,LTD.NCJWA 2.7XPR00020-0010603R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-0701. R

Event Narratives#

D

Patient 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.

N

Patient 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.