Food, drugs, devices › Johnson & Johnson Surgical Vision, Inc.
Device recall: Veritas Advanced Infusion Packs, REF: VRT-AI
Johnson & Johnson Surgical Vision, Inc. (Irvine, CA) initiated this device recall on 7 Dec 2022; FDA lists 3 product records under event 91290, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Johnson & Johnson Surgical Vision, Inc. has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Johnson & Johnson Surgical Vision, Inc., Irvine, CA.
Reason for recall
"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."
Distribution
"US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1005-2023 | Veritas Advanced Infusion Packs, REF: VRT-AI | 3133 | Class II | Ongoing | 1 Feb 2023 |
| Z-1006-2023 | FUSION Dual Pump Packs, REF: OPO73 | 7644 | Class II | Ongoing | 1 Feb 2023 |
| Z-1007-2023 | Single-Use Packs, REF: OPO80 | 384 | Class II | Ongoing | 1 Feb 2023 |
Context
Other enforcement events for Johnson & Johnson Surgical Vision, Inc.
All 15 events for Johnson & Johnson Surgical Vision, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.