VISCO360 VISCOSURGICAL SYSTEM 03916

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-05-03 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..

Event Text Entries

[74368363] 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. Mfr reference #: (b)(4). Submitted to fda on: 05/03/2017.
Patient Sequence No: 1, Text Type: N, H10


[74368364] The site reported that the microcatheter was severed while performing viscodilation. The entire device was removed from the eye. There is no known adverse impact to the patient.
Patient Sequence No: 1, Text Type: D, B5


[77254036]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010363671-2017-00018
MDR Report Key6540080
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2017-05-03
Date of Report2017-04-04
Date Mfgr Received2017-04-04
Device Manufacturer Date2017-01-03
Date Added to Maude2017-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANNE-MARIE RIPLEY
Manufacturer Street3000 SAND HILL RD., 3-105
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal94025
Manufacturer Phone6616458546
Manufacturer G1SIGHT SCIENCES, INC.
Manufacturer Street3000 SAND HILL RD., 3-105
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal Code94025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVISCO360 VISCOSURGICAL SYSTEM
Generic NameVISCOELASTIC INJECTOR
Product CodeMRH
Date Received2017-05-03
Returned To Mfg2017-05-04
Model Number03916
Catalog Number03916
Lot Number1005198
Device Expiration Date2017-12-31
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIGHT SCIENCES, INC.
Manufacturer Address3000 SAND HILL RD., 3-105 MENLO PARK CA 94025 US 94025


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-03

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