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Data / Medical devices / United States / Alcon Research, LLC

Alcon Research, LLC: FDA-registered device maker in Sinking Spring, PA, United States, 15 510(k) clearances and 2 PMA approvals

Alcon Research, LLC is registered with the FDA (registration 2523835) in Sinking Spring, PA, United States. It lists 23 device types. The FDA files 15 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 4, 2024. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Alcon Research, LLC
FDA registration number
2523835
Address
714 Columbia Ave., Sinking Spring, PA, United States, 19608
Owner or operator
Alcon Laboratories, Inc. (1610287)
Roles
Manufacturer, Manufacturer for export
First device listed
February 3, 1994
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Cautery, Radiofrequency, Ac-PoweredHQR2Manufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufactureraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Manufactureraccessdata.fda.gov
Cannula, Trocar, OphthalmicNGY1Manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Manufactureraccessdata.fda.gov
CystotomeHNY1Manufactureraccessdata.fda.gov
EndoilluminatorMPA2Manufactureraccessdata.fda.gov
Folders And Injectors, Intraocular Lens (Iol)MSS1Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufactureraccessdata.fda.gov
Implant, Eye ValveKYF2Manufactureraccessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE2Manufactureraccessdata.fda.gov
Intraocular Pressure Lowering ImplantOGO3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Knife, OphthalmicHNN1Manufactureraccessdata.fda.gov
Lens, Guide, IntraocularKYB1Manufactureraccessdata.fda.gov
Photocoagulator And AccessoriesHQB2Manufactureraccessdata.fda.gov
Sponge, OphthalmicHOZ2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyesterGAS2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Manufactureraccessdata.fda.gov
Unit, PhacofragmentationHQC2Manufactureraccessdata.fda.gov
Vitrectomy, Instrument CutterMLZ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 4, 2024K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);MPASubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
January 10, 2024K233902Centurion™ Vision System (Active Sentry™) (8065753057)HQCSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
August 23, 2021K212039CLAREON MONARCH IV IOL Delivery SystemMSSSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
November 1, 2019K191650LEGION SystemHQCSubstantially EquivalentAlcon Research, LLCaccessdata.fda.gov
March 22, 2017K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+MLZSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
August 22, 2014K141065CONSTELLATION VISION SYSTEMHQESubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
November 21, 2011K112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECEHQCSubstantially EquivalentAlcon Manufacturing, Ltd.accessdata.fda.gov
October 17, 2011K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAHQBSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
May 20, 2011K110166CLEARCUT S SAFETY KNIFEHNNSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
April 2, 2010K093305ENHANCED ULTRA VIT PROBEMLZSubstantially EquivalentAlcon Research, Ltd.accessdata.fda.gov
March 27, 2007K063155MONARCH III IOL DELIVERY SYSTEMKYBSubstantially EquivalentAlcon Manufacturing, Ltd.accessdata.fda.gov
March 26, 2002K012852EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONSKYFSubstantially EquivalentOptonol, Ltd.accessdata.fda.gov
December 17, 1993K930517NON-ABSORBABLE SURGICAL SUTURESGARSubstantially EquivalentAlcon Laboratoriesaccessdata.fda.gov
April 22, 1991K910245I/A HANDPIECE WITH REPLACEABLE TIPSGBXSubstantially EquivalentSurgical Technologies, Inc.accessdata.fda.gov
November 2, 1989K896004ALCON SURGICAL SPONGEHOZSubstantially EquivalentAlcon Laboratoriesaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 10, 2018P170034HYDRUS MICROSTENTOGO17June 4, 2026accessdata.fda.gov
July 29, 2016P150037CyPass Micro-StentOGO12April 9, 2020accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 28, 202392698Class IIOngoingConstellation Procedure PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.accessdata.fda.gov
August 28, 201880931Class ITerminatedCyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.accessdata.fda.gov

Compare with other makers

Updated June 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.