510(k) · Cleared
Recalled · Class II · 2023VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Surgical Vision, Inc. · HQC Unit, Phacofragmentation
Cleared on Mar 12, 2021 as substantially equivalent to K151636 (Abbott Medical Optics, Inc., 2015) and 1 other predicate after a 155-day review. Its family tree reaches back 5 generations to 1985. It has been recalled 3 times.
- Decided
- Mar 12, 2021
- Review
- 155 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844373 (1985). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 4 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 3 generations backK111446 Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. · 2011 · Recalled
- 2 generations backK133115 Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot…Abbott Medical Optics, Inc. · 2014 · Recalled
- 1 generation backK151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR…Abbott Medical Optics, Inc. · 2015
- This deviceK203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack…Johnson & Johnson Surgical Vision, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −4 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −3 | K111446 | Sovereign Compact Phacoemulsification System | Abbott Medical Optics, Inc. | 2011 | 1 |
| −2 | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal… | Abbott Medical Optics, Inc. | 2014 | 1 |
| −1 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature… | Abbott Medical Optics, Inc. | 2015 | — |
| 0 (this device) | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and… | Johnson & Johnson Surgical Vision, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Summary page 5…Name: Phacofragmentation System Product Code: HQC Primary Predicate Device: WhiteStar Signature Pro Phacoemulsification System, (K151636) VERITAS™ Vision System Secondary Predicate OPO73 Dual Pump Fluidics Pack (K160236) Device: VERITAS™ Packs Refer… | 2015 |
| * | K160236 | Dual Pump PackSummary page 5…ice: WhiteStar Signature Pro Phacoemulsification System, (K151636) VERITAS™ Vision System Secondary Predicate OPO73 Dual Pump Fluidics Pack (K160236) Device: VERITAS™ Packs Reference Predicate WhiteStar Signature Phacoemulsification System, (K111697, WhiteStar Devic… | 2016 |
| † | K111697 | Amo Whitestar Signature Phacoemulsification System | 2011 |
| † | K981116 | Sovereign Cataract Extraction System | 1998 |
| † | K162342 | Stellaris Elite Vision Enhancement System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2023 | Class II | Z-2247-2023 | Process control | 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… |
| Dec 7, 2022 | Class II | Z-1005-2023 | Process control | 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… |
| Sep 1, 2022 | Class II | Z-0086-2023 | Under Investigation by firm | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 9 of the 15 ancestors have a recall of any class.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements.
The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203060: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026