MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-04 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[71627417]
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).
Patient Sequence No: 1, Text Type: N, H10
[71627418]
The site reported that the microcatheter was severed while performing visco-dilation. The entire device was removed from the eye. At this time there is no known adverse impact to the patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00015 |
| MDR Report Key | 6456556 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer G1 | SIGHT SCIENCES, INC. |
| Manufacturer Street | 3000 SAND HILL RD., 3-105 |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| 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 | 2017-04-04 |
| Returned To Mfg | 2017-03-27 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005195 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-04-04 |