MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-05-03 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[74308208]
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: 05/03/2017.
Patient Sequence No: 1, Text Type: N, H10
[74308209]
The site reported that the microcatheter was severed while performing viscodilation. The entire device was removed from the eye. There is no known adverse impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[77850488]
After visual inspection and functional test of the returned device, it was determined that there was no malfunction in this device. (b)(4). Follow-up report submitted to fda on: 05/24/2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010363671-2017-00019 |
| MDR Report Key | 6540083 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-05-03 |
| Date of Report | 2017-04-04 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2017-05-03 |
| 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 | 2017-05-03 |
| Returned To Mfg | 2017-05-04 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005198 |
| 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 RD., 3-105 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-03 |