OMNI GLAUCOMA TREATMENT SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for OMNI GLAUCOMA TREATMENT SYSTEM manufactured by Omni / Sight Sciences, Inc..

Event Text Entries

[183869624] Pt underwent a trabeculectomy procedure (b)(6) 2020. Experienced a possible omni surgical device product failure. Pt returned (b)(6) 2020 related to increased ocular pressure. Second procedure to insert express short on (b)(6) 2020 was successful. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093771
MDR Report Key9839972
Date Received2020-03-16
Date of Report2020-03-12
Date of Event2020-01-27
Date Added to Maude2020-03-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOMNI GLAUCOMA TREATMENT SYSTEM
Generic NameTRABECULOTOME
Product CodeHMZ
Date Received2020-03-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOMNI / SIGHT SCIENCES, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-16

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