Recall Z-1005-2023

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: Process control

Action taken

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.