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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon

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  Class 2 Device Recall Horizon see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = AMERICAN OPTISURGICAL, INC.
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