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 2020-01-15 for STENT INJECT TRABECULAR MICRO BYPASS SYSTEM G2-M-IS manufactured by Glaukos Corporation.
[189055562]
Additional information: estimated based on the information received. The device was not available; therefore, product testing on the actual device could not be performed. The device history record review of the manufacturing lot was performed and there were non-conformities found to be related to the reported event. A review of the device labeling was completed. Hyphema, elevated iop and vitreous hemorrhage are identified in the labeling as known inherent risks of trabecular micro-bypass stent/cataract procedure. The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device. Based on the information received, the root cause of the reported event was likely due to patient post-op activity.
Patient Sequence No: 1, Text Type: N, H10
[189055703]
It was reported that following a right eye cataract plus trabecular micro bypass stent system, the patient presented with post-operative hyphema. Through follow-up, the surgeon reported that the procedure was uneventful. The reported hyphema was characterized graded as grade i (less than or equal to 1/3 of the anterior chamber volume) which was associated with iop increase and decreased vision. The patient was treated with steroids and glaucoma drops for one (1) week. The most recent status was reported as? Resolved and drops will be discontinued?. Reportedly, the patient was not on any anticoagulants. According to the surgeon, the patient? S movement with daily activities (postoperative) likely contributed to the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032546-2020-00010 |
| MDR Report Key | 9592708 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-15 |
| 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 | MRS. BRITTANY MASSEY |
| Manufacturer Street | 229 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 949367960 |
| Manufacturer G1 | GLAUKOS CORPORATION |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENT INJECT TRABECULAR MICRO BYPASS SYSTEM |
| Generic Name | INTRAOCULAR PRESSURE LOWERING IMPLANT |
| Product Code | OGO |
| Date Received | 2020-01-15 |
| Model Number | G2-M-IS |
| Lot Number | 126567 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAUKOS CORPORATION |
| Manufacturer Address | 229 AVENIDA FABRICANTE SAN CLEMENTE CA 92672 US 92672 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-01-15 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-15 |