Bausch & Lomb, Inc.: FDA clearances and approvals
Bausch & Lomb, Inc. has 102 FDA 510(k) clearances (first 1977, latest 2019), plus 30 PMA decisions, across 43 product codes in 7 review panels. Median 510(k) review time: 66 days. openFDA lists 78 product recalls by a recalling firm named Bausch & Lomb, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov. It files with the SEC as Bausch & Lomb Corp (BLCO).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 208 |
| 2013 | 4 | 138 |
| 2014 | 4 | 118 |
| 2015 | 1 | 28 |
| 2016 | 0 | — |
| 2017 | 1 | 28 |
| 2018 | 0 | — |
| 2019 | 1 | 67 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bausch & Lomb, Inc.'s cleared 510(k)s took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQL | Intraocular Lens | 15 | 0 |
| LPN | Accessories, Soft Lens Products | 15 | 15 |
| LPL | Lenses, Soft Contact, Daily Wear | 11 | 11 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 10 | 10 |
| HQC | Unit, Phacofragmentation | 9 | 9 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 6 | 6 |
| LPM | Lenses, Soft Contact, Extended Wear | 6 | 0 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 5 | 5 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 | 4 |
| HNO | Keratome, Ac-Powered | 4 | 4 |
Plus 33 more product codes.
Review panels
- Ophthalmic (115)
- Clinical Chemistry (6)
- Ear, Nose and Throat (4)
- Dental (3)
- General Hospital (1)
- Pathology (1)
- General and Plastic Surgery (1)
Most recent Bausch & Lomb, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | MSS | 2019-10-04 | 67 |
| K173480 | Crystalsert Lens Delivery System | MSS | 2017-12-11 | 28 |
| K151102 | Bausch + Lomb Injector System | MSS | 2015-05-22 | 28 |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | HQC | 2014-03-12 | 119 |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | HQC | 2014-02-14 | 116 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | MSS | 2014-01-09 | 196 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | MSS | 2014-01-03 | 78 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | MSS | 2013-12-27 | 141 |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | MSS | 2013-09-17 | 29 |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | 2013-09-11 | 135 |
92 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240005 | PMA | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | 2024-10-10 |
| P060022 | PMA | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | 2008-09-05 |
| P010062 | PMA | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR | 2004-06-07 |
| P030002 | PMA | CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | 2003-11-14 |
| P990014 | PMA | HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | 1999-11-12 |
Recalls
78 product recalls in 25 recall events; 0 initiated in the last five years. Most recent: 2018-08-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Bausch & Lomb, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06997003: Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2 (Recruiting, started 2025-06-16)
- NCT06767917: A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB (Completed, started 2024-11-26)
SEC filings
Bausch & Lomb Corp (BLCO): EDGAR filings, CIK 1860742. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Bausch & Lomb, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances does Bausch & Lomb, Inc. have?
Bausch & Lomb, Inc. has 102 FDA 510(k) clearances (first 1977, latest 2019), plus 30 PMA decisions, across 43 product codes in 7 review panels.
How long does FDA take to clear Bausch & Lomb, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bausch & Lomb, Inc.'s cleared 510(k)s is 66 days.
What devices does Bausch & Lomb, Inc. make?
Its most frequent FDA product codes are HQL (Intraocular Lens, 15); LPN (Accessories, Soft Lens Products, 15); LPL (Lenses, Soft Contact, Daily Wear, 11).
Has Bausch & Lomb, Inc. had device recalls?
openFDA lists 78 product recalls in 25 recall events by a recalling firm whose name matches Bausch & Lomb, Inc; the most recent began 2018-08-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 102 Bausch & Lomb, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Bausch & Lomb, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.