Recall Z-0086-2023 ยท HQC Unit, Phacofragmentation
Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
| Date | Oct 12, 2022 (initiated Sep 1, 2022) |
| Status | Open, Classified |
| Reason | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. |
| Root cause | Under Investigation by firm |
| Action | 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 VERIT |
| Quantity | 53,624 units |
| Distribution | Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece Johnson & Johnson Surgical Vision, Inc., Mar 12, 2021 |