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

Model Number 011014-001-K

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

Patient Problem No Code Available (3191)

Event Date 04/03/2013

Event Type  Injury  

Event Description

The patient was implanted with the argus ii device on (b)(6) 2012.The patient is participating in a post-market study of argus ii.This patient was diagnosed with hypotony on (b)(6) 2012.The patient was monitored for several months until (b)(6) 2013 when the intraocular pressure dropped to 1 mmhg, and the patient was scheduled for revision surgery.The surgery took place on (b)(6) 2013.During the procedure the surgeon noted possible leakage at the edge of the sclerotomy and he added extra sutures at the ciliary body and at the sclerotomy and a mattress suture at the sclerotomy.Intraocular pressure improved following the procedure.In (b)(6) 2013, hypotony was observed again.On (b)(6) 2013 a second revision surgery was performed in which the surgeon reattached the ciliary body in the inferior temporal quadrant.Intraocular pressure remained low.On (b)(6) 2013, the patient underwent another revision surgery in which the surgeon performed vitrectomy, ciliary body relief and extraction of the patient's intraocular lens.Intraocular pressure remained low following the procedure.The patient was scheduled for re-operation on (b)(6) 2013.On (b)(6) 2013, the patient had a pre-operative b-scan which showed a retinal detachment (refer to mdr 3004081696-2014-00014).On (b)(6) 2013, the patient underwent revision surgery in which the surgeon performed vitrectomy, retinotomy, filled the eye with silicone oil, and performed an iridotomy.There have been no further interventions since that time.The surgeon considered this event to be related to the initial surgical procedure.There was no defect or malfunction of the device associated with this event.

Manufacturer Narrative

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

• Brand Name: ARGUS II RETINAL 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: 4234459
• MDR Text Key: 4998331
• Report Number: 3004081696-2014-00013
• Device Sequence Number: 1
• Product Code: NBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H110002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2013

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: 03/01/2014
• Device Model Number: 011014-001-K
• Device Catalogue Number: 011014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR