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STAAR Surgical AG

Switzerland CH-MF-000039544 Last updated 23 Oct 2026 Part of Staar Surgical Co.

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Devices
1,365
Registries
EUDAMEDFDA
FDA recalls
2413 ongoing

Catalogue1,365

Page 1 of 28

Showing 1-50 of 1,365

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

Notified body 0344 2 certificates

  • 3830100CE01 Amended

    Quality management system EU MDR

    Issued
    15 Aug 2024
    Expires
    15 Jul 2027
    Reason
    Mnf ar change
  • 3830100TD01 Amended

    Technical documentation EU MDR

    Issued
    29 Jul 2025
    Expires
    15 Jul 2027
    Reason
    Other

Related companies

Authorised representatives

Notified bodies

  • Notified body 0344

FDA recalls24

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 24 recalls.

  • 2026

    • 20 Apr 2026 Z-2509-2026 Class II Ongoing Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
    • 21 Jan 2026 Z-1480-2026 Class II Ongoing 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 shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.

  • 2023

    • 29 Sep 2023 Z-0464-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0465-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0466-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0467-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0468-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0469-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0470-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0471-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Show all 24 recalls

  • 2023

    • 29 Sep 2023 Z-0472-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0473-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
    • 29 Sep 2023 Z-0474-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.

  • 2016

    • 2 May 2016 Z-1964-2016 Class II Terminated The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

  • 2013

    • 10 Jun 2013 Z-1746-2013 Class II Terminated 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.
    • 10 Jun 2013 Z-1747-2013 Class II Terminated 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.

  • 2011

    • 20 May 2011 Z-2706-2011 Unclassified (pre-2012) Terminated The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.

  • 2005

    • 18 Jul 2005 Z-1106-05 Unclassified (pre-2012) Terminated Sterility may be compromised.
    • 28 Mar 2005 Z-0775-05 Unclassified (pre-2012) Terminated Complaints of leaking with question of sterility and risk of infection in eye.

  • 2004

    • 17 Jun 2004 Z-1037-04 Unclassified (pre-2012) Terminated Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
    • 21 Apr 2004 Z-0957-04 Unclassified (pre-2012) Terminated Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
    • 23 Feb 2004 Z-0766-04 Unclassified (pre-2012) Terminated Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
    • 9 Feb 2004 Z-0539-04 Unclassified (pre-2012) Terminated Risk of hyperopic refractive changes.
    • 6 Jan 2004 Z-0378-04 Unclassified (pre-2012) Terminated Increased numbers of lens tears during placement of lens into eye.

Information

Country
Switzerland
Address
104, Hauptstrasse, Nidau, Switzerland
Website
www.staar.com
Phone
626 303 7902
PRRC contact
Izabela Wyss
EUDAMED SRN
CH-MF-000039544
FDA FEI number
3002808259