MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-08-03 for OMNI GLAUCOMA TREATMENT SYSTEM 1-101 manufactured by Sight Sciences, Inc..
[115955747]
The device was discarded by the facility and is not available for evaluation. Device did not provide lot number of device used. Mfr reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115955748]
On (b)(6) 2018, the surgeon performed vasodilation and trabeculotomy with the omni device on the patient's right eye. The surgeon then performed phacoemulsification and insertion of an intraocular lens. The surgeon administered intracameral cefuroxime 1mg/0. 1ml at the end of the procedure. There were no intraoperative complications. On (b)(6) 2018, the patient was diagnosed with mild-moderate corneal edema, iop elevation (28mhg), anterior chamber inflammation, hypopyon, and mild pain which was diagnosed as toxic anterior segment syndrome (tass). Patient's best corrected visual acuity had decreased from 0. 4 pre-operatively to 0. 2 at the onset of the event. No cultures were obtained. The patient was treated with topical cycloplegic drops (10 mg/ml of cyclopentolate hydrocloride) and azara (10 mg/ml plus 5 mg/ml of brinzolamide, timolol maleate). The event was resolved by (b)(6) 2018. The patient's iop has improved to 14 mmhg and the best corrected visual acuity has improved to 0. 7. No other cases of tass or endophthalmitis were reported at the facility around the time of the event. The surgeon did not believe the omni device was the cause or a contributing factor in this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2018-00001 |
| MDR Report Key | 7747644 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-08-03 |
| 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 | OMNI GLAUCOMA TREATMENT SYSTEM |
| Generic Name | VISCOELASTIC INJECTOR |
| Product Code | MRH |
| Date Received | 2018-08-03 |
| Model Number | 1-101 |
| Catalog Number | 1-101 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2018-08-03 |