This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
CATALYS PRECISION LASER SYSTEM - MAIN UNIT (2015-03-10)
- Starting date:
- March 10, 2015
- Posting date:
- April 14, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52851
Recalled Products
A. CATALYS PRECISION LASER SYSTEM - MAIN UNIT
Reason
AMO quality assurance was notified of a complaint that a patient's left eye was treated with a right eye template. The left eye cataract incisions template was selected as a starting basis for patient treatment planning. From there the right eye/ left eye cataract incisions template buttons were toggled which caused right eye cataract incisions template numbers to be auto populated into the left eye template. This is a software anomaly which translates into a potential incorrect treatment at an occurrence rate higher than established in the risk management file.
Affected products
A. CATALYS PRECISION LASER SYSTEM - MAIN UNIT
Lot or serial number
SOFTWARE VERSION 3.00.05
Model or catalog number
CATALYS SYSTEM-I
Companies
- Manufacturer
-
OPTIMEDICA CORPORATION
1310 MOFFETT PARK DRIVE
SUNNYVALE
94089
California
UNITED STATES