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

Model Number	03916
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product labeling lists iris injury as a potential risk of the device.All pertinent information available to (b)(4).Has been submitted.The company is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).
Event or Problem Description
During surgery on (b)(6)2017, the microcatheter was severed.The severed portion of the microcatheter had to be manually retrieved from schlemm's canal, during which a small iris defect (approximately 1 clock hour) was created.On a post-operative visit on(b)(6)2017, hyphema was observed.On (b)(6)2017, hyphema was still present, but mostly cleared.Due to the hyphema, the surgeon could not determine whether there were any adverse sequelae associated with the iris defect.

• Brand Name: VISCO360 VISCOSURGICAL SYSTEM
• Common Device Name: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill rd., 3-105; menlo park CA 94025
• MDR Report Key: 6679764
• Report Number: 3010363671-2017-00026
• Device Sequence Number: 1539305
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: (01)00858027006013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 03916
• Device Catalogue Number: 03916
• Device Lot Number: 1005191
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1