MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-05-10 for VISCO360 VISCOSURGICAL SYSTEM 05172 manufactured by Sight Sciences, Inc..
[74890312]
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: may10, 2017.
Patient Sequence No: 1, Text Type: N, H10
[74890314]
The patient underwent viscodilation with the visco360 device on (b)(6) 2017. On (b)(6) 2017, the patient was observed to have a fibrin reaction in the anterior chamber with ac inflammation (cells +++), conjunctival injection, and small hypopyon (<0. 05 mm). The patient reported mild pain and had a decreased visual acuity. An ultrasound b scan was done. A vitrectomy was performed and the eye was cultured on (b)(6) 2017. The patient responded well to treatment and the visual acuity has improved to the pre-operative level as of (b)(6) 2017. The doctor did not think that the visco360 device contributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00020 |
| MDR Report Key | 6559494 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2016-12-12 |
| Date Added to Maude | 2017-05-10 |
| 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 | 2017-05-10 |
| Model Number | 05172 |
| Catalog Number | 05172 |
| Lot Number | 1005123 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-05-10 |