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U.S. Department of Health and Human Services

Class 2 Device Recall Veritas Advanced Infusion Packs

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  Class 2 Device Recall Veritas Advanced Infusion Packs see related information
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
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
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
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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