MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for VISCO360 VISCOSURGICAL SYSTEM 03916 manufactured by Sight Sciences, Inc..
[67812604]
All pertinent information available to sight sciences, inc. Has been submitted. The company is submitting this mdr to ensure full compliance with 21 cfr part 803. The device was discarded by the facility and is not available for evaluation. The device history records (manufacturing and sterilization) were reviewed and there were no discrepancies or unusual findings that relate to the reported event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67812605]
On (b)(6) 2017, the patient had uneventful cataract surgery followed by vasodilation of schlemm's canal in the left eye. Two days postoperatively the patient was diagnosed with tass with associated anterior chamber inflammation, hypopyon, increased white blood cells in the anterior chamber, and decreased visual acuity. Preoperatively, the patient's best corrected visual acuity (bcva) was 20/40; at onset, bcva decreased to 20/100 and iop was measured at 14 mmhg. The patient was treated with topical steroids, topical antibiotics, and an intravitreal injection. The eye was cultured and results were negative for bacteria and fungus. On february 16, 2017, the doctor reported that the patient was fully recovered with an uncorrected visual acuity of 20/50 and a pinhole acuity of 20/30. There have been no other reports of tass at this surgical facility and the association between the event and the device is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2017-00001 |
| MDR Report Key | 6343187 |
| Date Received | 2017-02-20 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-21 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-02-20 |
| 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 | 0 |
| Brand Name | VISCO360 VISCOSURGICAL SYSTEM |
| Generic Name | VISCOELASTIC INJECTOR |
| Product Code | MRH |
| Date Received | 2017-02-20 |
| Model Number | 03916 |
| Catalog Number | 03916 |
| Lot Number | 1005195 |
| 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 | 1. Required No Informationntervention | 2017-02-20 |