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

Model Number 03916

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

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

Event Date 01/21/2017

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 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 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
• Type of Device: VISCOELASTIC INJECTOR
• Manufacturer (Section D): SIGHT SCIENCES, INC.; 3000 sand hill road, 3-105; menlo park CA 94025
• Manufacturer Contact: anne-marie ripley ; 3000 sand hill road, 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 6343187
• MDR Text Key: 67812604
• Report Number: 3010363671-2017-00001
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• 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: 03916
• Device Catalogue Number: 03916
• Device Lot Number: 1005195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CATARACT SURGERY; HEALON GV USED IN VISCO360 DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR