MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	GTS100R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.Any omitted information was not available at the time of initial report.Foreign body sensation and blurry vision are identified in the device labeling as known inherent risks of glaucoma stent surgery.Mfr reference # (b)(4).
Event or Problem Description
The surgeon reported that a clinical trial patient presented on postoperative day one (1) with report of a mild intermittent foreign body sensation.The patient was prescribed artificial tears.On postoperative day 15 the patient presented with blurry vision/visual disturbance for which artificial tears were continued.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 6888975
• Report Number: 2032546-2017-00081
• Device Sequence Number: 13655546
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 111033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR