Recall Z-2247-2023 ยท HQC Unit, Phacofragmentation
Johnson & Johnson Surgical Vision, Inc.
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
| Date | Jul 28, 2023 (initiated May 30, 2023) |
| Status | Open, Classified |
| Reason | Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, 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. |
| Root cause | Process control |
| Action | On 5/30/23, recall notices were mailed to customers who were asked to do the following: 1) Discontinue use and return affected devices to the recalling firm. 2) Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred. 3) Complete and return the customer reply form to RegCompliOne@its.jnj.com In addition, distributors were asked to distribute the recall notice to their customers. Questions, adverse events, and complaints can be directed to the firm at 1-877-266-4543 Option 2. |
| Quantity | 148,941 |
| Distribution | Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO, AR, DE, IL, WI, VA, NJ, LA, SC, HI, OR, VT, MN, NV, CO and the countries of Argentina, Australia, Austria, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, Chil |
| 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 |