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iLux
Alcon Laboratories, Inc. · Model 2020-D · UDI-DI 00864461000418
ORZ
Prescription
10
510(k) clearances
37
Adverse events
3
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Sight Sciences, Inc. | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not ev |
| 2017-01-30 | Tearscience, Inc | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. |
| 2016-09-13 | Tearscience, Inc | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.