FDA.reportPublic FDA data

MAUDE MDR 2928885

MDR report key
2928885
Report number
3019924-2013-00002
Event key
0
Event type
3
Date of event
2012-12-21
Date received
2013-01-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
8415 154TH AVE., N.E. REDMOND WA 98052 US
Phone
425-425-4255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MALYUGIN RING SYSTEMIRIS RETRACTORMICROSURGICAL TECHNOLOGY, INC.HNIMAL-0002MAL-0002UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-01-1601. O

Event Narratives#

D

Patient 1

WHEN THE SURGEON ATTEMPTED TO REMOVE A MALYUGIN RING A SMALL STRAND OF IRIS BECAME TANGLED IN THE RING. THE SURGEON THOUGHT THE SMALL STRAND WOULD TEAR EASILY AND TUGGED ON THE IRIS CAUSING A TEAR AND BLEEDING. A SECOND ATTEMPT TO REMOVE THE RING WITH THE INSERTER WAS SUCCESSFUL.

N

Patient 1

THE PT?S IRIS WAS BOUND DOWN WITH SYNECHIA. THE SURGEON CLEARED THE SYNECHIA 360 DEGREES WITH VISCOAT AND AFTERWARD THE IRIS HAD SIGNIFICANT PROLAPSE WITH ONE OF THE EYELETS OF THE RING PROTRUDING INTO THE INCISION. UPON COMPLETING CATARACT REMOVAL THE RING WAS DISENGAGED BUT THE IRIS HAD A MOTH-EATEN CONSISTENCY AND A PORTION OF THE IRIS HAD BECOME ENTANGLED IN THE RING RESULTING IN THE EVENT. THE SURGEON REPORTED THE INCISION WAS TOO SHORT AND FOUR SUTURES WERE USED TO CLOSE THE WOUND. THE SURGEON EXPECTED THE BLOOD TO CLEAR IN A COUPLE OF MONTHS AND THE PT TO FULLY RECOVER.