Is Veritas Advanced Infusion Packs, REF: VRT-AI recalled?

Medium RiskFDA Device

Johnson & Johnson Surgical Vision, Inc.: 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.

Agency Publication Date: January 20, 2023

Affected Products

Product: Veritas Advanced Infusion Packs, REF: VRT-AI

UDI-DI/Lots: 05050474700901/60400378, 60401981, 60401982

Product: FUSION Dual Pump Packs, REF: OPO73

UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197

Product: Single-Use Packs, REF: OPO80

UDI-DI/Lot: 05050474573352/60326033

Lot Numbers:

05050474573352

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91290

Status: Active

Manufacturer: Johnson & Johnson Surgical Vision, Inc.

Manufactured In: United States

Units Affected: 3 products (3133; 7644; 384)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.