FDA Device recall Z-1005-2023
Veritas Advanced Infusion Packs, REF: VRT-AI
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Veritas Advanced Infusion Packs, REF: VRT-AI by Johnson And Johnson Surgical Vision, citing 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 delivere….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1005-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Johnson And Johnson Surgical Vision |
| Distribution | FL, IL, MN, MS, NY, OH, TN, TX |
Product
Veritas Advanced Infusion Packs, REF: VRT-AI
Reason
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.
Identifiers
| code_info | UDI-DI/Lots: 05050474700901/60400378, 60401981, 60401982 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1005-2023%22
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