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

Model Number 03916

Device Problem Detachment Of Device Component (1104)

Patient Problems Eye Injury (1845); Hyphema (1911)

Event Date 06/08/2017

Event Type  malfunction  

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 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
• 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: 6679764
• MDR Text Key: 78784773
• Report Number: 3010363671-2017-00026
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: (01)00858027006013
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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: 1005191
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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