FDA.reportPublic FDA data

MAUDE MDR 592012

MDR report key
592012
Report number
MW1035171
Event key
0
Event type
3
Date of event
2005-03-10
Date received
2005-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MSIDISPOSABLE IRIS RETRACTORSMSIHNI*135016-5161238NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-04-120

Event Narratives#

D

Patient 1

IRIS RETRACTORS INSERTED TEMPORARILY IN THE EYE DURING CATARACT SURGERY. WHEN BEING REMOVED FROM THE EYE THE HOOKS AT THE END OF THE DEVICE BROKE OFF IN THE EYE.