MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-28 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[71054872]
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. Mfr reference #: (b)(4). Submitted to fda on: 03/28/2017.
Patient Sequence No: 1, Text Type: N, H10
[71054873]
The surgeon reports severing the microcatheter while performing viscodilation. The microcatheter separated from the device when retracting it from schlemm's canal. The entire device was removed successfully 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 | 3010363671-2017-00008 |
| MDR Report Key | 6438996 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-28 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2017-03-28 |
| 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 ROAD, 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 | 2017-03-28 |
| Returned To Mfg | 2017-02-13 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005160 |
| Device Expiration Date | 2017-11-30 |
| 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 | 2017-03-28 |