| Class 2 Device Recall Veritas Advanced Infusion Packs | |
Date Initiated by Firm | December 07, 2022 |
Date Posted | January 20, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1005-2023 |
Recall Event ID |
91290 |
510(K)Number | K203060 |
Product Classification |
Unit, phacofragmentation - Product Code HQC
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Product | Veritas Advanced Infusion Packs, REF: VRT-AI |
Code Information |
UDI-DI/Lots: 05050474700901/60400378, 60401981, 60401982 |
Recalling Firm/ Manufacturer |
Johnson & Johnson Surgical Vision, Inc. 31 Technology Dr Ste 200 Irvine CA 92618-2302
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Manufacturer Reason for Recall | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. |
FDA Determined Cause 2 | Process control |
Action | On 12/07/22, recall notices were sent to customers who were asked to do the following:
1) Discontinue using affected product.
2) Return product to the recalling firm.
3) Complete and return the Customer Reply form via email to RegCompliOne@its.jnj.com
4) Distributors, distribute the recall notice to your customers.
Customers with questions or concerns can call the firm at 1-877-266-4543 Option 2. |
Quantity in Commerce | 3133 |
Distribution | US: FL, MS, NY, TN, TX, IL, MN, OH.
OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HQC
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