MAUDE Adverse Event Report: SECOND SIGHT MEDICAL PRODUCTS INC. ARGUS II PROSTHESIS; RETINAL PROSTHESIS

Model Number 011013-001-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/29/2013

Event Type  Injury  

Event Description

The patient was implanted with the argus ii device on (b)(6) 2011.On (b)(6) 2013, the patient was diagnosed with hypotony, rubeosis iridis, corneal neovascularization, descemet folds and a slight tyndall.Ultrasound showed no choroidal detachment.Patient was prescribed medications.On (b)(6) 2013, the patient was diagnosed with a mild choroidal detachment and the medication were continued.The event continued and on (b)(6) 2013, the surgeon performed a revision surgery on the patient in which he re-sutured around the cable and applied a scleral patch over the sclerotomy.On (b)(6) 2014, the patient was seen for a follow-up visit and the hypotony was still unresolved.On (b)(6) 2014, the patient had a second revision surgery in which the surgeon injected silicone oil into his eye.On (b)(6) 2014, the patient had a follow-up visit and the hypotony is still present.The patient was prescribed eye drops (cortisone and trobadex).There was no defect of malfunction of the device associated with this event.

Manufacturer Narrative

All pertinent information available to second sight medical products, inc.Has been submitted.The company is submitting this mdr to ensure full compliance with 21 cfr 803.

• Brand Name: ARGUS II PROSTHESIS
• Type of Device: RETINAL PROSTHESIS
• Manufacturer (Section D): SECOND SIGHT MEDICAL PRODUCTS INC.; 12744 san fernando rd bldg 3; sylmar CA 91342 000
• Manufacturer Contact: anne-marie ripley ; 12744 san fernando rd bldg 3; sylmar, CA 91342-0000 ; 8188335034
• MDR Report Key: 4234460
• MDR Text Key: 20787044
• Report Number: 3004081696-2014-00012
• Device Sequence Number: 1
• Product Code: NBF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H110002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2013
• Device Model Number: 011013-001-K
• Device Catalogue Number: 011013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR