Data / Medical devices / Ireland / Johnson & Johnson Vision Care Ireland Unlimited Company
Johnson & Johnson Vision Care Ireland Unlimited Company: FDA-registered device maker in . Limerick(County), Ireland, 9 510(k) clearances and 2 PMA approvals
Johnson & Johnson Vision Care Ireland Unlimited Company is registered with the FDA (registration 9617710) in . Limerick(County), Ireland. It lists 3 device types. The FDA files 9 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 29, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9617710
- FEI number
- 3003083595
- Address
- The National Technology Park, . Limerick(County), Ireland, .
- Owner or operator
- Johnson & Johnson Vision Care, Inc. (1024871)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| March 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| March 3, 2008 | K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| August 12, 2005 | K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | MVN | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 4, 2004 | K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 23, 2000 | K994324 | ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPL | Substantially Equivalent | Vistakon, Johnson & Johnson Vision Products, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 20, 2005 | P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPM | 143 | October 16, 2026 | accessdata.fda.gov |
| March 18, 1980 | N18033 | ACUVUE CONTACT LENS | LPM | 107 | April 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Lens, Contact, (Disposable)
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.