gms | German Medical Science

Artificial Vision 2013

The International Symposium on Visual Prosthetics

08.11. - 09.11.2013, Aachen

Safety profile in the Argus® II Retinal Prosthesis System post-market patients

Meeting Abstract

  • Gregoire Cosendai - Second Sight Medical Products, Sàrl, Lausanne, Switzerland
  • P. Walter - Aachen, Germany
  • A. Augustin - Karlsruhe, Germany
  • B. Kirchhof - Köln, Germany
  • J. Sahel - CHNO des Quinze-Vingts, INSERM-DHOS CIC 503, Paris, France
  • L. Da Cruz - London, UK
  • S. Rizzo - Pisa, Italy
  • F. Arevalo - Riyadh, KSA

Artificial Vision 2013. Aachen, 08.-09.11.2013. Düsseldorf: German Medical Science GMS Publishing House; 2014. Doc13artvis31

doi: 10.3205/13artvis31, urn:nbn:de:0183-13artvis310

Published: February 13, 2014

© 2014 Cosendai et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Purpose: The Argus II Retinal Prosthesis System (Argus II) is the first and only artificial retina widely approved for market use (2011 CE mark in Europe, 2013 US FDA approval). In the commercial setting, it has since been implanted in 29 patients blinded by Retinitis Pigmentosa in 9 surgical centers in Italy, Germany, France, Netherlands, Saudi Arabia, and the UK. A post-market surveillance study has been started with the purpose to evaluate the safety profile of the approved device during commercial use compared to that observed in the investigational clinical study.

Methods: Safety data in the post-market setting has been collected from the day of surgery through August 2013, covering on average 10.2 months (median 9.2 months, range from 0.6 to 22 months) of exposure. The demographic distribution is: 11 female and 18 male patients, average age 52.9 years (range 31.0 - 74.0 years). The device was implanted OD in 17 patients and OS in 12 patients.

Results: Two of the 29 subjects have experienced serious adverse events that required a surgical procedure to treat. The first patient had an exposed suture led to conjunctival erosion which required repair. The second patient had hypotony that was treated with additional sutures and injection of saline. In addition, there were 16 non-serious adverse events (AEs) related to the surgical procedure: anterior chamber inflammation (1), fainting (2), conjunctival erosion (1), conjunctival irritation (1), high IOP (2), nausea/vomiting (3) experienced by 9 patients. These events were as follows: anterior chamber inflammation (1), fainting (2), hypotony (1), misshapen pupil (1), retinal tear (1), slight conjunctival injection (1), and syncope (1). There were also 6 non-serious, device-related events: decrease in light perception (1), headache (1), macular edema (1), ocular pain (1), revision of array placement (1), and vertigo (1). As was the case in the clinical trial, the majority of AEs (68%) occurred within the first month of implant, 14% occurred between 1-3 months, and the remainder of the events occurred between 6-12 months.

Conclusions: The first group of Argus II patients using the commercially available device demonstrates a safety profile that is, at 10 months post implantation, markedly better than that observed in the developmental phase of Argus II.