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