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HEALON EndoCoat (2014-11-17)
- Starting date:
- November 17, 2014
- Posting date:
- November 28, 2014
- 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-42683
Recalled Products
HEALON EndoCoat
Reason
This recall results from complaints received in the united states regarding the detachment of the HEALON EndoCoat Opthalmic Viscoelastic Device (OVD) finger grip. An advisory notice is being disseminated to customers to re-emphasize proper techniques for the use of the syringe included in the HEALON EndoCoat Directions For Use (DFU).
Affected products
HEALON EndoCoat
Lot or serial number
All lots.
Model or catalog number
VT585
Companies
- Manufacturer
-
Abbott Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana
92705
California
UNITED STATES