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CATALYS PRECISION LASER SYSTEM - MAIN UNIT (2015-03-11)
- Starting date:
- March 11, 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-52859
Recalled Products
A. CATALYS PRECISION LASER SYSTEM - MAIN UNIT
Reason
A remote, potential event was identified where loss of suction during treatment with the Catalys Precision Laser System, could create a hazardous situation that may result in scoring of the posterior surface during the performance of an anterior capsulotomy and phacofragmentation and/or creation of a single plane and multi-plane arc cuts/incisions in the cornea.
Affected products
A. CATALYS PRECISION LASER SYSTEM - MAIN UNIT
Lot or serial number
software version 2.20
Model or catalog number
CATALYS SYSTEM-I
Companies
- Manufacturer
-
OPTIMEDICA CORPORATION
1310 MOFFETT PARK DRIVE
SUNNYVALE
94089
California
UNITED STATES