Health product recall

Argus II Retinal Prosthesis Kit (2018-09-04)

Starting date:
September 4, 2018
Posting date:
October 19, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67958

Affected products

Argus II Retinal Prosthesis Kit

Reason

It was discovered that the ability to clone a Video Processing Unit (VPU) from the patient's data transfer file is not available to the programmer when the patient is implanted with the following specific models of the Argus II Retinal Prosthesis: device identifier 011015-001-K and 011016-001-K.

Affected products

Argus II Retinal Prosthesis Kit

Lot or serial number

All Serial Numbers, contact manufacturer.

Model or catalog number
  • 011015-001-K
  • 011016-001-K
Companies
Manufacturer

Second Sight Medical Products, Inc.

12744 San Fernando Road, Building 3

Sylmar

91342

California

UNITED STATES