FDA.reportPublic FDA data

MAUDE MDR 3909136

MDR report key
3909136
Report number
3005347768-2014-00001
Event key
0
Event type
3
Date received
2014-06-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
BORIS ARADOVSKY
Address
21 YEGIA KAPAYIM ST. 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 MINIATURE TELESCOPEVISIONCARE OPHTHALMIC TECHNOLOGIES LTD.NCJR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-050

Event Narratives#

D

Patient 1

RER IMP # (B)(4).

N

Patient 1

ANOTHER DEVICE FROM THE SAME BATCH WAS IMPLANTED AT A DIFFERENT USER FACILITY ON (B)(6) 2014 AND NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PT. THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED FOR THE BATCH OF THE DEVICE INVOLVED AND NO DEVIATIONS WERE FOUND. VISIONCARE BATCHES (B)(4) WERE STERILIZED IN THE SAME STERILIZATION LOAD. SIXTEEN DEVICE FROM THESE BATCHES WERE IMPLANTED IN PTS BETWEEN (B)(6) 2013 AND (B)(6) 2014 AND NO COMPLAINTS HAVE BEEN RECEIVED. STERILIZATION AND DEVICE BIOBURDEN VALIDATION ARE ROUTINELY CARRIED OUT BY VISIONCARE OPHTHALMIC TECHNOLOGIES AND NO DEVIATIONS HAVE BEEN FOUND. A REVIEW OF THE PREVIOUS ADVERSE EVENT REPORTED IN 2012 SHOWED INFECTION BY THE SAME SOURCE-(B)(6). THIS PREVIOUS EVENT WAS A RESULT OF THE PT RUBBING THEIR EYE AS REPORTED BY THE PT'S FAMILY. NO OTHER ADVERSE EVENTS OR COMPLAINTS RESULTING FROM INFECTIONS IN THE EYE HAVE BEEN RECEIVED BY VISIONCARE.