MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-28 for VISCO360 VISCOSURGICAL SYSTEM 05172 manufactured by Sight Sciences, Inc..
[71102643]
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
[71102644]
The visco360 device was used to viscodilate schlemm's canal in a patient with refractory glaucoma. The surgeon reported advancing the microcatheter 180 degrees in the canal and resistance was encountered when attempting to retract the microcatheter and viscodilate. Shortly afterwards, the microcatheter severed. Using retinal forceps, the surgeon successfully removed the catheter from the eye by performing a 180 degree goniotomy with the microcatheter. He elected to remove the device with a goniotomy since he had already been considering performing goniotomy during this procedure to treat the patient's refractory glaucoma. Using a new visco360 device, the surgeon then successfully performed viscodilation of the remaining 180 degrees of schlemm's canal. The event did not result in an adverse impact to the patient. The patient's day 1 iop was reported to be 18 mmhg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00009 |
| MDR Report Key | 6439251 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-28 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-12-07 |
| 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 | 05172 |
| Catalog Number | 05172 |
| Lot Number | 1005114 |
| 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 ROAD, 3-105 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-28 |