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

Model Number	03916
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypopyon (1913); Inflammation (1932); Visual Impairment (2138)
Date of Event	01/21/2017
Type of Reportable Event	Serious Injury
Additional 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 part 803.The device was discarded by the facility and is not available for evaluation.The device history records (manufacturing and sterilization) were reviewed and there were no discrepancies or unusual findings that relate to the reported event.(b)(4).
Event or Problem Description
On (b)(6) 2017, the patient had uneventful cataract surgery followed by vasodilation of schlemm's canal in the left eye.Two days postoperatively the patient was diagnosed with tass with associated anterior chamber inflammation, hypopyon, increased white blood cells in the anterior chamber, and decreased visual acuity.Preoperatively, the patient's best corrected visual acuity (bcva) was 20/40; at onset, bcva decreased to 20/100 and iop was measured at 14 mmhg.The patient was treated with topical steroids, topical antibiotics, and an intravitreal injection.The eye was cultured and results were negative for bacteria and fungus.On february 16, 2017, the doctor reported that the patient was fully recovered with an uncorrected visual acuity of 20/50 and a pinhole acuity of 20/30.There have been no other reports of tass at this surgical facility and the association between the event and the device is unknown.

• Brand Name: VISCO360 VISCOSURGICAL SYSTEM
• Common Device Name: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill road, 3-105; menlo park CA 94025
• MDR Report Key: 6343187
• Report Number: 3010363671-2017-00001
• Device Sequence Number: 13559285
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: (01)00858027006013
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 03916
• Device Catalogue Number: 03916
• Device Lot Number: 1005195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATARACT SURGERY; HEALON GV USED IN VISCO360 DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR