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Data / Medical devices / Folders And Injectors, Intraocular Lens (Iol)

Folders And Injectors, Intraocular Lens (Iol) (MSS): 29 FDA-registered makers in 7 countries

29 establishments in 7 countries are registered with the FDA to make Folders And Injectors, Intraocular Lens (Iol) (product code MSS, Class 1, 21 CFR 886.4300). 22 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on June 10, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MSS
Device class
1
Regulation
886.4300
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States21
Switzerland2
India2
Barbados1
Netherlands1
Japan1
Taiwan1

Makers of Folders And Injectors, Intraocular Lens (Iol)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Manufacturer, Specification developer14October 10, 2024000api.fda.gov
Bausch & Lomb IncorporatedClearwater, FL, United StatesManufacturer7December 11, 2017010api.fda.gov
Lenstec Barbados, Inc.Christ Church, BarbadosManufacturer5November 29, 2016000api.fda.gov
Staar Surgical CompanyMonrovia, CA, United StatesComplaint file establishment, Manufacturer5September 6, 2017000api.fda.gov
STAAR Surgical CompanyTustin, CA, United StatesSpecification developer5September 6, 2017000api.fda.gov
AST Products, Inc.Billerica, MA, United StatesSpecification developer4June 4, 2020000api.fda.gov
Lenstec, Inc.Saint Petersburg, FL, United StatesSpecification developer4November 29, 2016000api.fda.gov
Amo Puerto Rico Manufacturing, IncAnasco, PR, United StatesManufacturer3September 13, 2019000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer3September 13, 2019000api.fda.gov
Medicel AGAltenrhein Sankt Gallen, SwitzerlandContract manufacturer, Manufacturer3September 16, 2025000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer2November 7, 2007000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesManufacturer, Repackager or relabeler2November 7, 2007000api.fda.gov
RxSight Inc.Aliso Viejo, CA, United StatesManufacturer2August 15, 2023000api.fda.gov
Amo Groningen BVGroningen, NetherlandsManufacturer1September 13, 2019000api.fda.gov
Alcon Research, LLCHuntington, WV, United StatesManufacturer1January 5, 2001000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1August 23, 2021000api.fda.gov
Alcon Research, LLCFort Worth, TX, United StatesSpecification developer1August 23, 2021010api.fda.gov
Alcon Research, LLCLesage, WV, United StatesManufacturer1January 5, 2001000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer1January 9, 2014000api.fda.gov
Carl Zeiss Meditec Production, LLC.Ontario, CA, United StatesManufacturer1April 15, 2013010api.fda.gov
Hoya Surgical Research CenterTokyo, JapanSpecification developer1March 23, 2009000api.fda.gov
Icares Medicus, Inc.Zhubei Hsinchu(County), TaiwanContract manufacturer, Manufacturer1June 4, 2020000api.fda.gov
AurolabMADURAI Tamil Nadu, IndiaContract manufacturer0000api.fda.gov
Cima Technology, Inc.Pittsburgh, PA, United StatesManufacturer for export0000api.fda.gov
Jellisee Ophthalmics Inc.McLean, VA, United StatesManufacturer for export0000api.fda.gov
Omni Lens Pvt. Ltd.Gandhinagar Gujarat, IndiaContract manufacturer0000api.fda.gov
Ophthalmic Solution Inc.Knoxville, TN, United StatesManufacturer for export0000api.fda.gov
Sdi Surgical Device International GMBHBruegg Bern, SwitzerlandContract manufacturer0000api.fda.gov
U.S. Iol, Inc.Lexington, KY, United StatesManufacturer for export0000api.fda.gov

Updated June 10, 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.