FDA.reportPublic FDA data

MAUDE MDR 6439506

MDR report key
6439506
Report number
3010363671-2017-00010
Event key
0
Event type
3
Date of event
2017-02-22
Date received
2017-03-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANNE-MARIE RIPLEY
Address
3000 SAND HILL ROAD, 3-105 MENLO PARK CA 94025 US
Phone
661-661-6616
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VISCO360 VISCOSURGICAL SYSTEMVISCOELASTIC INJECTORSIGHT SCIENCES, INC.MRH03916039161005077R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-280

Event Narratives#

N

Patient 1

THE DEVICE INSTRUCTIONS FOR USE WERE REVIEWED. THEY WERE FOUND TO BE ADEQUATE AND WITH NO DEFICIENCIES. A REVIEW OF THE PRODUCT LOT HISTORY RECORDS FOR THIS LOT OF DEVICES DID NOT REVEAL ANY PRODUCTION NONCONFORMANCE, ANOMALY OR ANY OTHER BACKGROUND THAT WOULD HELP EXPLAIN THE CIRCUMSTANCES FOR THIS COMPLAINT. THE DEVICE WAS DISCARDED BY THE FACILITY AND IS NOT AVAILABLE FOR EVALUATION. ALL PERTINENT INFORMATION AVAILABLE TO SIGHT SCIENCES, INC. HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR 803. (B)(4).

D

Patient 1

THE SURGEON REPORTED THAT THE TIP OF THE MICROCATHETER WAS SEVERED DURING USE. THE SEVERED PORTION OF THE DEVICE WAS REMOVED FROM THE EYE WITHOUT INCIDENT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE SURGEON REPORTED THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE ADVERSE EVENTS ASSOCIATED WITH THIS DEVICE ISSUE.