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

Model Number 05172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypopyon (1913); Inflammation (1932); Visual Impairment (2138)

Event Date 04/05/2017

Event Type  Injury  

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.(b)(4).Submitted to fda on: may10, 2017.

Event Description

The patient underwent viscodilation with the visco360 device on (b)(6) 2017.On (b)(6) 2017, the patient was observed to have a fibrin reaction in the anterior chamber with ac inflammation (cells +++), conjunctival injection, and small hypopyon (<0.05 mm).The patient reported mild pain and had a decreased visual acuity.An ultrasound b scan was done.A vitrectomy was performed and the eye was cultured on (b)(6) 2017.The patient responded well to treatment and the visual acuity has improved to the pre-operative level as of (b)(6) 2017.The doctor did not think that the visco360 device contributed to this event.

• 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: 6559494
• MDR Text Key: 74890312
• Report Number: 3010363671-2017-00020
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006020
• UDI-Public: (01)00858027006020(17)171231(10)1005123
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 05172
• Device Catalogue Number: 05172
• Device Lot Number: 1005123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR