Recall Z-1808-2009 ยท HQC Unit, Phacofragmentation
American Optisurgical Inc
American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
| Date | Sep 4, 2009 (initiated Mar 24, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| Action | 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 u |
| Quantity | 12 units |
| Distribution | Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020527 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 American Optisurgical, Inc., Jul 9, 2002 |