Open, Classified

VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

FDA Recall Z-2247-2023 · Posted 2023-07-28

Recalling FirmJohnson & Johnson Surgical Vision, Inc.

Recall StatusOpen, Classified

Product CodeHQC

Date Initiated2023-05-30

Product Quantity148,941

Reason for Recall

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.

Firm 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 [email protected] 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.

Root Cause

Process control

Distribution Pattern

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, Chile, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Korea¿(South), Kuwait, Lebanon, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc. · 2021-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.