Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2247-2023 — VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

U.S. FDA — Device Enforcement · United States · 2023-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2247-2023
Date of alert
2023-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Johnson & Johnson Surgical Vision, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05050474700901
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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