Facility

STAAR SURGICAL AG

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

Key facts

5recalls · 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)	3002808259
Establishment type	Manufacture Medical Device
Location	104 HAUPTSTRASSE NIDAU Bern, CH CH-2560
Registration status	Active · expires 2026
Parent company	STAAR SURGICAL Company (owner-operator 2023826)
Brand names	Implantable Collamer Lens; EVO+ VISIAN Implantable Collamer Lens; EVO VISIAN Toric Implantable Collamer Lens; EVO+ VISIAN Toric Implantable Collamer Lens; EVO VISIAN Implantable Collamer Lens

Activity by year

Recalls (5)

Devices registered here (2)

Phakic Toric Intraocular Lens
Product code QCB (opens in a new tab) · Class III · Ophthalmic · 21 CFR 886.3600
Lens, Intraocular, Phakic
Product code MTA (opens in a new tab) · Class III · Unknown

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “STAAR SURGICAL AG (FEI 3002808259) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808259-staar-surgical-ag/

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