Luxottica North America Distribution LLC
Mason, OH, US
Luxottica North America Distribution LLC appears in FDA device records in Mason, OH. FDA records list no 510(k) clearances, no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Luxottica North America Distribution LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Luxotticarecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1035170 | 1035170 | Luxottica North America Distribution LLC | 4000 LUXOTTICA PLACE, MASON, OH 45040 US | 2026 | No device listings on this registration |
| 3002774493 | 3002774493 | Luxottica North America Distribution LLC | 100 GREENWOOD INDUSTRIAL PARK, Mc Donough, GA 30253 US | 2026 | No device listings on this registration |
| 3004075893 | 3004075893 | Luxottica North America Distribution LLC | 2150 Bixby Road, Lockbourne, OH 43137 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0542-2010 | Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106 | The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Luxottica North America Distribution LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain