16
Sep
2009

Cl Il American Optisurgical

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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