RegWardenFDA facility compliance records
Facility

Iridex Corporation

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

Activity by year

FDA actions on record by year2016: 1 inspections; 2018: 1 recalls; 2023: 1 inspections12016201712018201920202021202212023202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2018-02-27
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

FDA inspections (2)

  • NAI2023-09-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
  • NAI2016-08-19
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

Related

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. “Iridex Corporation (FEI 2939653) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2939653-iridex-corporation/

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