| Class 2 Device Recall Horizon |  |
Date Initiated by Firm | March 24, 2009 |
Date Posted | September 04, 2009 |
Recall Status1 |
Terminated 3 on September 04, 2009 |
Recall Number | Z-1808-2009 |
Recall Event ID |
52697 |
510(K)Number | K020527 |
Product Classification |
phacoemulsification system - Product Code HQC
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Product | American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. |
Code Information |
Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129. |
Recalling Firm/ Manufacturer |
American Optisurgical Inc 25501 Arctic Ocean Dr Lake Forest CA 92630
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For Additional Information Contact | 949-580-1266 Ext. 211 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 12 units |
Distribution | Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HQC
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