Medical device manufacturer
Bausch and Lomb, Incorporated
Bausch and Lomb, Incorporated holds 137 FDA 510(k) clearances across 34 product codes. Median elapsed review time is 75 days. openFDA lists 82 recall records naming the company. FDA publishes it under 17 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 137
- Product codes
- 34
- Median review
- 75 days
- Recall records
- 82
How does FDA spell Bausch and Lomb, Incorporated?
FDA publishes this company under 17 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Bausch & Lomb | device/recall | normalised |
| Bausch & Lomb | device/510k | normalised |
| Bausch & Lomb Inc | device/recall | normalised |
| Bausch & Lomb Inc | device/enforcement | normalised |
| Bausch & Lomb Incorporated | device/recall | normalised |
| Bausch & Lomb Incorporated | device/registrationlisting | normalised |
| Bausch & Lomb, Inc. | device/recall | normalised |
| Bausch & Lomb, Inc. | device/enforcement | normalised |
Showing 8 of 17.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Bausch and Lomb, Incorporated file in?
34 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 20 | 87 days | |
| LPN | Accessories, Soft Lens Products | 20 | 89 days | |
| HQC | Unit, Phacofragmentation | 15 | 116 days | |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 12 | 67 days | |
| HQD | Lens, Contact (Other Material) - Daily | 8 | 89 days | |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 6 | 18 days | |
| HPX | Lens, Contact (Polymethylmethacrylate) | 5 | 53 days | |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 5 | 59 days | |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 | 10 days | |
| HNO | Keratome, Ac-Powered | 4 | 30 days | |
| MVN | Lens, Contact, (Disposable) | 4 | 57 days | |
| ESD | Hearing Aid, Air-Conduction, Prescription | 3 | 35 days | |
| LRX | Case, Contact Lens | 3 | 28 days | |
| HKO | Refractometer, Ophthalmic | 2 | 10 days | |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 2 | 41 days | |
| HOS | Projector, Ophthalmic | 2 | 19 days | |
| JEQ | Toothbrush, Powered | 2 | 70 days | |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 2 | 80 days | |
| MOE | Collagen Corneal Shield | 2 | 98 days | |
| EFS | Unit, Oral Irrigation | 1 | 35 days | |
| GEX | Powered Laser Surgical Instrument | 1 | 90 days | |
| HKY | Tonometer, Manual | 1 | 74 days | |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 1 | 41 days | |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | 41 days | |
| HQF | Laser, Ophthalmic | 1 | 53 days |
Showing the 25 they file in most, of 34.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Bausch and Lomb, Incorporated had a recall?
openFDA lists 82 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-3265-2018Class IITerminatedHQE
The back cap separates from the body of the vitrectomy cutter.
Z-3266-2018Class IITerminatedHQE
The back cap separates from the body of the vitrectomy cutter.
Z-3267-2018Class IITerminatedHQE
The back cap separates from the body of the vitrectomy cutter.
Z-3268-2018Class IITerminatedHQE
The back cap separates from the body of the vitrectomy cutter.
Z-3269-2018Class IITerminatedHQE
The back cap separates from the body of the vitrectomy cutter.
Showing the 5 most recently initiated of 82.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Bausch and Lomb, Incorporated cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | HQC | 29 | |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | HQC | 267 | |
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | MSS | 59 | |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | HQC | 186 | |
| K232084 | Stellaris Elite vision enhancement system | HQC | 228 | |
| K230954 | Samfilcon B Custom Contact Lens | LPL | 227 | |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | LPL | 370 | |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | LPN | 106 | |
| K211786 | Independent Corneal Viewing Chamber (IVC-21) | LYX | 177 | |
| K202932 | ABT12 multi-purpose solution | LPN | 241 |
Source: openFDA device/510k · retrieved
Where is Bausch and Lomb, Incorporated registered?
FDA lists 9 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Bausch and Lomb, Incorporated files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.