Company:American Optisurgical Inc.
Date of Enforcement Report 9/16/2009
Class:ll
PRODUCT
American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Recall # Z-1808-2009
REASON
Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.
RECALLING FIRM/MANUFACTURER
American Optisurgical Inc., Lake Forest, CA, by e-mail on April 2, 2009. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide, Brazil, Algeria, France, South Korea, India, and Peru