Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

On 09/01-02/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day Mail to customers informing them that the firm is recalling specific lots of VERITAS Advanced Infusion Packs due to the potential for the irrigation luer to crack or break which could lead to reduced irrigation pressure during surgery, associated with an unstable anterior chamber. Customers are required to: 1.Identify if any of their inventory contains VERITAS Packs with a lot number listed on page 5. 2.Immediately discontinue using and remove from their inventory all affected VERITAS Packs. No other VERITAS Advanced Infusion Packs are affected by this recall. 3.Complete the attached Customer Reply Form (on page 4). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. If customers have product to be returned: -Complete the Customer Reply Form, noting the lot numbers of the VERITAS Packs. -Contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return. -Email Customer Reply Form to [email protected] within 3 business days of receipt of this letter. - A credit will be issued upon receipt of the customer reply form and product. If you do not have product to be returned: Email Customer Reply Form to [email protected] For questions or concerns, contact 1-877-266-4543 Option 2.