American Optisurgical Inc American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.

Distribution

As reported by FDA

CA