MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-28 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[71105340]
The device instructions for use were reviewed. They were found to be adequate and with no deficiencies. A review of the product lot history records for this lot of devices did not reveal any production nonconformance, anomaly or any other background that would help explain the circumstances for this complaint. The device was discarded by the facility and is not available for evaluation. 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
[71105341]
The surgeon reported that the tip of the microcatheter was severed during use. The severed portion of the device was removed from the eye without incident. A new device was used to complete the case. The surgeon reported there were no intra-operative or post-operative adverse events associated with this device issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00010 |
| MDR Report Key | 6439506 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-28 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-22 |
| 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 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005077 |
| Device Expiration Date | 2017-11-30 |
| 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 ROAD, 3-105 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-28 |