MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-29 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[78784773]
The product labeling lists iris injury as a potential risk of the device. All pertinent information available to (b)(4). Has been submitted. The company is submitting this mdr to ensure full compliance with 21 cfr part 803. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[78784774]
During surgery on (b)(6)2017, the microcatheter was severed. The severed portion of the microcatheter had to be manually retrieved from schlemm's canal, during which a small iris defect (approximately 1 clock hour) was created. On a post-operative visit on(b)(6)2017, hyphema was observed. On (b)(6)2017, hyphema was still present, but mostly cleared. Due to the hyphema, the surgeon could not determine whether there were any adverse sequelae associated with the iris defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00026 |
| MDR Report Key | 6679764 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-06-09 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-06-29 |
| 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 | 2017-06-29 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005191 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIGHT SCIENCES, INC. |
| Manufacturer Address | 3000 SAND HILL RD., 3-105 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-29 |