MAUDE Adverse Event Report: SIGHT SCIENCES, INC. VISCO360 VISCOSURGICAL SYSTEM; VISCOELASTIC INJECTOR

Model Number 03916

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: VISCO360 VISCOSURGICAL SYSTEM
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer (Section G): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 3000 sand hill rd., 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 6540080
• MDR Text Key: 74368363
• Report Number: 3010363671-2017-00018
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: (01)00858027006013(17)171231(10)1005198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 03916
• Device Catalogue Number: 03916
• Device Lot Number: 1005198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1