MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for TRAB360 TRABECULOTOMY SYSTEM 03706 manufactured by Sight Sciences, Inc..
[71203101]
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. Mfr reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71203102]
The surgeon reported severing the tip of the trabeculotome while performing a trabeculotomy. The entire device was removed from the eye without incident. A new device was successfully used to complete the case. The event did not result in any adverse impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[73469411]
Corrected data: the initial report contained an error where the 510(k) number provided was incorrect. This device involved in this event is 510(k) exempt and there is no associated 510(k) number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010363671-2017-00003 |
| MDR Report Key | 6433193 |
| Date Received | 2017-03-24 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2017-03-24 |
| 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 | TRAB360 TRABECULOTOMY SYSTEM |
| Generic Name | TRABECULOTOME |
| Product Code | HMZ |
| Date Received | 2017-03-24 |
| Returned To Mfg | 2016-12-02 |
| Model Number | 03706 |
| Catalog Number | 03706 |
| Device Expiration Date | 2017-11-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-24 |