| Class 2 Device Recall COMPLETE MultiPurpose Solution | |
Date Initiated by Firm | July 23, 2010 |
Date Posted | November 02, 2010 |
Recall Status1 |
Terminated 3 on October 13, 2011 |
Recall Number | Z-0129-2011 |
Recall Event ID |
56735 |
510(K)Number | K014202 |
Product Classification |
Soft Lens Products Accessories - Product Code LPN
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Product | AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml).
Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day. |
Code Information |
Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225. |
Recalling Firm/ Manufacturer |
Abbott Medical Optics Inc (AMO) 1700 E Saint Andrew Pl Santa Ana CA 92705
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For Additional Information Contact | 714-247-8656 |
Manufacturer Reason for Recall | The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening. |
FDA Determined Cause 2 | Pending |
Action | AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products.
Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663. |
Quantity in Commerce | 34,080 units |
Distribution | International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France. |
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 = LPN
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