Johnson & Johnson Surgical Vision, Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Johnson & Johnson Surgical Vision, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (10)
FDA medical device enforcement actions by Johnson & Johnson Surgical Vision, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 14, 2024 | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Tes... | Due to a manufacturing variation of the irrigation sleeves which could result... | Class II |
| Dec 12, 2023 | TECNIS Toric II OptiBlue IOL Models ZCW | Due to intraocular lens containing an angle out of specification (OOS). The ... | Class II |
| Jul 6, 2023 | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with u... | Class II |
| Jul 6, 2023 | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with u... | Class II |
| May 30, 2023 | VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ... | Weld protrusion/physical gap between the housing and pack cover, may exceed d... | Class II |
| Dec 7, 2022 | Single-Use Packs, REF: OPO80 | Weld protrusion/physical gap between the housing and phaco pack cover, may ex... | Class II |
| Dec 7, 2022 | Veritas Advanced Infusion Packs, REF: VRT-AI | Weld protrusion/physical gap between the housing and phaco pack cover, may ex... | Class II |
| Dec 7, 2022 | FUSION Dual Pump Packs, REF: OPO73 | Weld protrusion/physical gap between the housing and phaco pack cover, may ex... | Class II |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional nav... | Class II |
| Sep 1, 2022 | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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