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

Model Number 03916

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2017

Event Type  malfunction  

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: 03/24/2017.

Event Description

The visco360 device was used on (b)(6) 2017 to perform viscodilation of schlemm's canal on the right eye.After fully retracting the catheter from the first 180 degrees of dilation of schlemm's canal, the surgeon noticed a very small blue fragment entangled in the iris (presumably from the microcatheter).The surgeon was able to complete the procedure and viscodilate the remaining 180 degrees of the canal, but elected to leave the fragment in the iris due to concerns about potential complications involved in its removal.On (b)(6) 2017 surgeon reported the patient's post-operative iop was 8 mmhg with some hyphema.On (b)(6) 2017, the surgeon reported that the patient was healing well with an iop of 11 mmhg (unmedicated).He was able to view the fragment under high magnification and estimated it was 10-20 microns.The fragment was observed in the same area where the trabecular meshwork was accessed to perform viscodilation.Additional information has been requested.

Manufacturer Narrative

(b)(4).Submitted to fda on: 03/28/2017.

Manufacturer Narrative

Additional data provided in response to letter dated may 10, 2017.This supplemental report is being re-submitted since the prior attempt to submit this information failed.Mfr reference number: (b)(4).

• 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 rd., 3-105; menlo park, CA 94025 ; 6616458546
• MDR Report Key: 6431427
• MDR Text Key: 70770415
• Report Number: 3010363671-2017-00002
• Device Sequence Number: 1
• Product Code: MRH
• UDI-Device Identifier: 00858027006013
• UDI-Public: 0100858027006013
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• 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
• Patient Age: 62 YR