Facility

Alcon Research, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010208880
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	20511 Lake Forest Dr Lake Forest, CA, US 92630
Registration status	Active · expires 2026
Parent company	Alcon Laboratories, Inc. (owner-operator 1610287)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Unit, Phacofragmentation
Product code HQC (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.4670
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Product code HQE (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.4150

Recalls & enforcement

Class IITerminated2018-07-17
Potential for the optical head to detach from the stand due to the lack of thread adhesive.

FDA inspections (1)

NAI2018-03-19
No Action Indicated · Radiation Control and Health Safety Act

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Alcon Research, LLC (FEI 3010208880) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010208880-alcon-research-llc/

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