MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-16 for OMNI SURGICAL SYSTEM 05600 1-100 manufactured by Sight Sciences, Inc..
[133339974]
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. Mfr reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133339975]
On (b)(6) 2018, the surgeon advanced the microcatheter of the omni surgical system into schlemm's canal. As he began to retract the microcatheter, he observed that is was detached from cannula and remained in the canal. He grasped the detached portion with forceps and completed the goniotomy superiorly. He then used the forceps to thread the microcatheter into the other direction of schlemm's canal and created a goniotomy inferiorly. He then removed the microcatheter from the eye with the forceps. There were no intraoperative or post-operative complications associated with this product issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010363671-2019-00001 |
| MDR Report Key | 8254038 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2018-07-13 |
| Date Added to Maude | 2019-01-16 |
| 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 SURGICAL SYSTEM |
| Generic Name | VISCOELASTIC INJECTOR |
| Product Code | MRH |
| Date Received | 2019-01-16 |
| Returned To Mfg | 2019-01-02 |
| Model Number | 05600 |
| Catalog Number | 1-100 |
| Lot Number | 1006652 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-16 |