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Ora System 2000 Intraopertive Wavefront Aberrometer
- Starting date:
- July 14, 2017
- Posting date:
- August 14, 2017
- 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-64166
Reason
Through remote monitoring of the intraocular lens (IOL) databases on installed ORA Carts, Alcon has determined that that a small number of ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery.
Affected products
Ora System 2000 Intraopertive Wavefront Aberrometer
Lot or serial number
- 1601274801X1
- 1601320201X1
- 1601321001X
- 1601321301X
- 1601321601X
- 1603716401X
- C4239R
- C4286R
Model or catalog number
- 00380659983078
- ORA SYSTEM 2000
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES