Day

September 16, 2009
16
Sep

Cl Il American Optisurgical

September 16, 2009
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...
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