Johnson & Johnson Surgical Vision, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Johnson & Johnson Surgical Vision, Inc.” (first 2019, latest 2023), plus 7 PMA decisions, across 6 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 40 |
| 2020 | 0 | — |
| 2021 | 1 | 155 |
| 2022 | 0 | — |
| 2023 | 1 | 136 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Johnson & Johnson Surgical Vision, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQL | Intraocular Lens | 3 | 0 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| LZP | Aid, Surgical, Viscoelastic | 2 | 0 |
| MFK | Lens, Multifocal Intraocular | 2 | 0 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
| OOE | Ophthalmic Femtosecond Laser | 1 | 1 |
Review panels
- Ophthalmic (11)
Most recent Johnson & Johnson Surgical Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | OOE | 2023-04-14 | 136 |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | HQC | 2021-03-12 | 155 |
| K191949 | UNFOLDER Vitan Inserter | MSS | 2019-09-13 | 53 |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | HQC | 2019-08-16 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110007 | PMA | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) | 2012-07-02 |
| P080010 | PMA | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | 2009-01-16 |
| P990080 | PMA | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | 2001-04-05 |
| P980040 | PMA | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | 2000-02-03 |
| P960028 | PMA | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | 1997-09-05 |
Recalls
18 product recalls in 15 recall events; 12 initiated in the last five years. Most recent: 2026-07-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 27 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06377514: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens (Completed, started 2024-06-03)
- NCT06250322: A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens (Completed, started 2024-04-10)
- NCT05991960: Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL (Completed, started 2023-09-11)
- NCT06005675: User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL (Completed, started 2023-09-06)
- NCT05531292: PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002 (Completed, started 2022-11-22)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Johnson & Johnson Professionals, Inc. (206 510(k)s)
- Johnson & Johnson Medical, Inc. (53 510(k)s)
- Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
- Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
- Johnson & Johnson (14 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson International (10 510(k)s)
- Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
- Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
- Johnson & Johnson Patient Care, Inc. (4 510(k)s)
- Johnson & Johnson Medical, Ltd. (3 510(k)s)
- Johnson & Johnson Consumer, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson Surgical Vision, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Johnson & Johnson Surgical Vision, Inc.” (first 2019, latest 2023), plus 7 PMA decisions, across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Johnson & Johnson Surgical Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Surgical Vision, Inc. is 94 days. Since 2017: 94 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Johnson & Johnson Surgical Vision, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 3); HQC (Unit, Phacofragmentation, 2); LZP (Aid, Surgical, Viscoelastic, 2).
Next steps
- See all 4 Johnson & Johnson Surgical Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Johnson & Johnson Surgical Vision, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.