MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-24 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[70770415]
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.
Patient Sequence No: 1, Text Type: N, H10
[70770416]
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.
Patient Sequence No: 1, Text Type: D, B5
[71594822]
(b)(4). Submitted to fda on: 03/28/2017.
Patient Sequence No: 1, Text Type: N, H10
[116897339]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010363671-2017-00002 |
| MDR Report Key | 6431427 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-24 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE-MARIE RIPLEY |
| Manufacturer Street | 3000 SAND HILL RD., 3-105 |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6616458546 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCO360 VISCOSURGICAL SYSTEM |
| Generic Name | VISCOELASTIC INJECTOR |
| Product Code | MRH |
| Date Received | 2017-03-24 |
| Returned To Mfg | 2017-03-01 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005191 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIGHT SCIENCES, INC. |
| Manufacturer Address | 3000 SAND HILL ROAD, 3-105 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |