STAAR Surgical AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000039544 FEI 3002808259
Part of Staar Surgical Co.
- Devices
- 2,843
- Registrations
- EUDAMEDFDA
- FDA recalls
- 2413 ongoing
Catalogue
EVO+ Visian Toric ICL Ref VTICM5 12.1
EVO Visian Toric ICL Ref VTICMO 12.6
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 12.6
EVO+ Visian Toric ICL Ref VTICM5 13.7
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 13.2
Visian Toric ICL Ref VTICH 11.6
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 13.2
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 13.7
EVO+ Visian Toric ICL Ref VTICM5 12.1
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 12.1
EVO Visian Toric ICL Ref VTICMO 12.6
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 13.2
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 13.2
EVO+ Visian Toric ICL Ref VTICM5 13.2
EVO+ Visian Toric ICL Ref VTICM5 12.6
EVO Visian Toric ICL Ref VTICMO 12.6
EVO+ Visian Toric ICL Ref VTICM5 12.6
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 12.6
EVO Visian Toric ICL Ref VTICMO 13.2
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 12.6
EVO Visian Toric ICL Ref VTICMO 12.1
Visian Toric ICL Ref VTICH 12.1
Visian Toric ICL Ref VTICH 11.6
Visian Toric ICL Ref VTICH 12.1
Visian Toric ICL Ref VTICH 12.6
Visian Toric ICL Ref VTICH 12.1
Visian Toric ICL Ref VTICH 11.6
Visian Toric ICL Ref VTICH 11.6
Visian Toric ICL Ref VTICH 13.2
Visian Toric ICL Ref VTICH 12.1
Visian Toric ICL Ref VTICH 11.6
Visian Toric ICL Ref VTICH 12.6
EVO Visian Toric ICL Ref VTICMO 12.1
EVO Visian Toric ICL Ref VTICMO 12.6
Visian Toric ICL Ref VTICH 12.6
Visian Toric ICL Ref VTICH 12.1
Visian Toric ICL Ref VTICH 13.2
EVO Visian Toric ICL Ref VTICMO 13.7
EVO Visian Toric ICL Ref VTICMO 12.6
EVO+ Visian Toric ICL Ref VTICM5 13.2
Showing 1,751-1,800 of 2,843
Company details
- EUDAMED SRN
- CH-MF-000039544
- FDA FEI number
- 3002808259
- EUDAMED status
- Active
- EUDAMED registered name
- STAAR Surgical AG
- EUDAMED abbreviated name
- STAAR AG
- Registered address
- 104, Hauptstrasse, CH2560, Nidau, Switzerland
- Website
- www.staar.com
- [email protected]
- Phone
- 626 303 7902
- PRRC contact
- Izabela Wyss
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 15 Jul 2027
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
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 11
- 2024 0
- 2025 0
- 2026 2
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.
Full distribution text
- 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.
- 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.
2023
- 29 Sep 2023 Z-0464-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0465-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0466-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0467-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0468-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0469-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0470-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0471-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0464-2024 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.
Full distribution text
- 29 Sep 2023 Z-0473-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0474-2024 Class II Ongoing Their is a potential that intraocular implant devices may not meet specifications.
Full distribution text
- 29 Sep 2023 Z-0472-2024 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.
Full distribution text
- 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.
Full distribution text
- 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.
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.
Frequently asked questions
How many devices does STAAR Surgical AG have in the registry?
The registry currently lists 2843 devices for STAAR Surgical AG. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for STAAR Surgical AG?
FDA recall records list 24 recalls initiated by STAAR Surgical AG, the most recent initiated on 2026-04-20. 13 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for STAAR Surgical AG?
EUDAMED lists 2 certificates for STAAR Surgical AG (quality management system; technical documentation) under MDR. The most recent was issued on 2025-07-29.