Facility

OPTONOL, LTD

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3003701944
Establishment type	Manufacture Medical Device
Location	COMMUNICATION CENTER NEVE ILAN Central, IL 90850
Registration status	Active · expires 2026
Parent company	Alcon Laboratories, Inc. (owner-operator 1610287)

Activity by year

Recalls (1)

Devices registered here (1)

Implant, Eye Valve
Product code KYF (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.3920

Recalls & enforcement

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

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. “OPTONOL, LTD (FEI 3003701944) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003701944-optonol-ltd/

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