RegWardenFDA facility compliance records
Company

STAAR SURGICAL Company

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2016: 1 recalls; 2023: 1 recalls; 2026: 2 recalls1’13’14’151’16’17’18’19’20’21’221’23’24’252’26
  • Recalls (5)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2026-04-20
    Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
  • Class IIOngoing2026-01-21
    Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant s…
  • Class IIOngoing2023-09-29
    Their is a potential that intraocular implant devices may not meet specifications.
  • Class IITerminated2016-05-02
    The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
  • Class IITerminated2013-06-10
    STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “STAAR SURGICAL Company — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2023826-staar-surgical-company/

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