Recall Z-2247-2023— Johnson & Johnson Surgical Vision, Inc.
Class II · Ongoing
Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2023-05-30. It names one FDA 510(k) clearance: K203060. Product: VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF). 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..
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-30
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.