FDA.reportPublic FDA data

MAUDE MDR 4349843

MDR report key
4349843
Report number
3005347768-2014-00002
Event key
0
Event type
3
Date received
2014-11-19
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 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 TELESCOPETELESCOPE IMPLANTABLE MINIATURENCJR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-190

Event Narratives#

D

Patient 1

(B)(4).

N

Patient 1

ANOTHER DEVICE FROM THE SAME LOT (10506) WAS IMPLANTED AT A DIFFERENT USER FACILITY ON (B)(6) 2014 AND NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT. THE DEVICE HISTORY RECORD (DHR) FOR LOT 156 WAS REVIEWED AND NO DEVIATIONS WERE FOUND. SPECIAL ATTENTION WAS PAID TO THE FOLLOWING PROCESSES: INCOMING INSPECTION OF SHORT TUBE AND WINDOWS; BLOWING TEST FIRST AND SECOND WELDING; LEAK TEST RESULTS FROM FIRST AND SECOND LEAK TEST; STERILIZATION PROCESS RECORDS. REVIEW OF MDR, CUSTOMER COMPLAINTS AND RMA HISTORY WAS CARRIED OUT AND NO ISSUES WHICH MAY BE A SOURCE OF A DEVICE PROBLEM WERE FOUND. THE DEVICE WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2014 AND VISIONCARE HAS REQUESTED THAT IT BE RETURNED TO THEM FOR INVESTIGATION.