Data / Medical devices / United States / Carl Zeiss Meditec Production, LLC.
Carl Zeiss Meditec Production, LLC.: FDA-registered device maker in Ontario, CA, United States, 1 510(k) clearance and 1 PMA approval
Carl Zeiss Meditec Production, LLC. is registered with the FDA (registration 3010126268) in Ontario, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 15, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010126268
- Address
- 1040 S Vintage Ave BLDG A, Ontario, CA, United States, 91761
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- January 6, 2015
- Registered through
- 2026
- Brand names listed
- CT LUCIA 201P, CT LUCIA 201PY, CT LUCIA 202, CT LUCIA 211P, CT LUCIA 211PY, CT LUCIA 221P, CT LUCIA 601P, CT LUCIA 601PY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Complaint file establishment, Manufacturer, Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| April 15, 2013 | K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | MSS | Substantially Equivalent | Aaren Scientific, 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 |
|---|---|---|---|---|---|---|
| October 19, 2010 | P100016 | EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL | HQL | 24 | October 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 1, 2017 | 78037 | Class II | Terminated | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's. | The recommended storage temperature on the label is incorrect. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 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.