Accessories, Soft Lens Products
FDA product code LPN · Class II (moderate risk) · 21 CFR 886.5928 · Ophthalmic
121510(k) clearances
0PMA approvals
18recalls
Manufacturers
- Bausch & Lomb, Inc. 20
- Alcon Laboratories 15
- Ciba Vision Corporation 14
- Allergan, Inc. 12
- Sauflon Pharmaceuticals, Ltd. 4
- Polymer Technology Corp. 4
- Optics Laboratory, Inc. 3
- Menicon Co, Ltd. 3
- Advanced Medical Optics, Inc. 3
- Alcon Universal, Ltd. 3
- Alcon 3
- Szabocsik and Associates 2
- Cachet Pharmaceuticals Pvt. , Ltd. 2
- Alcon Research LLC 2
- Chemtex USA, Inc. 2
- Ciba Vision Care 1
- Wesley Jessen Corp. 1
- Allergan Optical 1
- Ote North America, LLC 1
- Ryder Intl. Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 08/13/2026SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | Bausch & Lomb, Incorporated | 12/06/2022SE |
| K221263 | Aqua Naina Plus Sterile Saline SolutionLPN · Special | Chemtex USA, Inc. | 10/12/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | Bausch & Lomb, Incorporated | 05/28/2021SE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional | Ote North America, LLC | 05/26/2021SE |
| K193441 | Aqua Naina Sterile Saline SolutionLPN · Traditional | Chemtex USA, Inc. | 05/26/2020SE |
| K200747 | PuriLens Plus Preservative Free SalineLPN · Traditional | The Lifestyle Company, Inc. | 05/15/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 03/02/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | Allergan, Inc. | 08/08/2019SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 07/31/2019SE |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline SolutionLPN · Traditional | Bausch & Lomb, Incorporated | 04/11/2017SE |
| K161819 | NNR06 Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Incorporated | 11/25/2016SE |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 10/19/2016SE |
| K161622 | LensGiene Sterile Saline SolutionLPN · Traditional | Optics Laboratory, Inc. | 08/11/2016SE |
| K151768 | Menicon Saline Rinse SolutionLPN · Traditional | Menicon Co, Ltd. | 08/28/2015SE |
| K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeLPN · Traditional | Alcon Laboratories, Inc. | 01/26/2015SE |
| K132216 | Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Special | Bausch & Lomb, Incorporated | 09/09/2013SE |
| K130734 | Sauflon Multipurpose SolutionLPN · Traditional | Sauflon Pharmaceuticals, Ltd. | 05/15/2013SE |
| K112909 | OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionLPN · Traditional | Bausch & Lomb, Inc. | 04/30/2012SE |
| K111877 | EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting…LPN · Traditional | Bausch & Lomb, Inc. | 01/24/2012SE |
| K110221 | Eye-Cept Sterile Saline SolutionLPN · Traditional | Optics Laboratory, Inc. | 11/01/2011SE |
| K102860 | Alcon Multi-Pirpose Disinfecting SolutionLPN · Traditional | Alcon Research, Ltd. | 05/10/2011SE |
| K102165 | Sterile Saline SolutionLPN · Traditional | Cachet Pharmaceuticals Pvt. , Ltd. | 01/19/2011SE |
| K093254 | Amo Brand Multi-Purpose Disinfecting SolutionLPN · Traditional | Abbott Medical Optics, Inc. | 09/15/2010SE |
| K093367 | Sterile Saline SolutionLPN · Traditional | Cachet Pharmaceuticals Pvt. , Ltd. | 09/10/2010SE |
| K083812 | Refresh Optive Lens Comfort Rewetting DropsLPN · Traditional | Allergan, Inc. | 07/09/2009SE |
| K071236 | Alcon Multi-Purpose SolutionLPN · Traditional | Alcon, Inc. | 12/12/2007SE |
| K070767 | Eye See Multipurpose Contact Lens SolutionLPN · Traditional | Lapis Lazuli International NV | 07/24/2007SE |
| K071203 | Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact LensesLPN · Traditional | Optikem International, Inc. | 06/13/2007SE |
| K062332 | Altaire MPS#1 Multipurpose Contact Lens SolutionLPN · Traditional | Altaire Pharmaceuticals, Inc. | 04/25/2007SE |
| K060924 | JSZ Multiaction GP Contact Lens SolutionLPN · Traditional | Szabocsik and Associates | 06/28/2006SE |
| K051104 | Eye See Multipurpose, No-Rub Contact Lens SolutionLPN · Traditional | Lapis Lazuli, NV | 05/31/2006SE |
| K050729 | Alcon Multi-Purpose Disinfecting SolutionLPN · Traditional | Alcon Research, Ltd. | 09/14/2005SE |
| K050250 | Aquify Multipurpose SolutionLPN · Traditional | Ciba Vision Corporation | 08/10/2005SE |
| K042562 | Lens Plus Rewetting DropsLPN · Abbreviated | Advanced Medical Optics, Inc. | 07/29/2005SE |
| K041008 | Eye-Cept Rewetting DropsLPN · Traditional | Optics Laboratory, Inc. | 07/01/2005SE |
| K050517 | Jsz-Multipurpose SolutionLPN · Traditional | Szabocsik and Associates | 04/13/2005SE |
| K042176 | Aquify Lens Comfort DropsLPN · Traditional | Ciba Vision Corporation | 11/03/2004SE |
| K031753 | Karats Multipurpose SolutionLPN · Traditional | Ciba Vision Corporation | 10/28/2004SE |
| K033608 | Aquify Multi-Purpose SolutionLPN · Special | Ciba Vision Corporation | 02/02/2004SE |
| K031646 | Bausch & Lomb Multi-Purpose Solution NRC03LPN · Traditional | Bausch & Lomb, Inc. | 11/14/2003SE |
| K032481 | Theratears Contact Lens Comfort DropsLPN · Traditional | Advanced Vision Research, Inc. | 11/04/2003SE |
| K030910 | Clued Up Multipurpose Solution- No RubLPN · Traditional | Clued UP Limited | 10/10/2003SE |
| K032030 | Blink CL Lubricant Eye DropsLPN · Traditional | Advanced Medical Optics, Inc. | 09/25/2003SE |
| K030522 | Aosept Clear Care Cleaning and Disinfecting SolutionLPN · Traditional | Ciba Vision Corporation | 09/12/2003SE |
| K031957 | Modification to Karats Multi-Purpose SolutionLPN · Traditional | Ciba Vision Corporation | 08/14/2003SE |
| K030278 | Sauflon Multipurpose Solution - No RubLPN · Traditional | Sauflon Pharmaceuticals, Ltd. | 07/30/2003SE |
| K031193 | Soft (Hydrophilic) Contact Lens Care SolutionLPN · Traditional | Alcon, Inc. | 07/03/2003SE |
| K031522 | Solo-Care Plus Multipurpose SolutionLPN · Traditional | Ciba Vision Corporation | 06/27/2003SE |
| K031521 | Aosept Clear Care Cleaning and Disinfecting SolutionLPN · Traditional | Ciba Vision Corporation | 06/27/2003SE |
| K030092 | Complete Brand Multi-Purpose SolutionLPN · Traditional | Advanced Medical Optics, Inc. | 04/04/2003SE |
| K021635 | Karats Multipurpose SolutionLPN · Traditional | Ciba Vision Corporation | 10/28/2002SE |
| K021143 | Opti-Free Express Multi-Purpose Disinfecting SolutionLPN · Traditional | Alcon Universal, Ltd. | 08/08/2002SE |
| K014202 | Complete Brand Multi-Purpose SolutionLPN · Traditional | Allergan, Inc. | 02/20/2002SE |
| K013479 | Complete Brand Multi-Purpose SolutionLPN · Traditional | Allergan, Inc. | 02/11/2002SE |
| K012731 | Solo-Care Plus Multipurpose SolutionLPN · Traditional | Ciba Vision Corporation | 12/26/2001SE |
| K013512 | Aosept Clear Care Cleaning and Disinfecting SolutionLPN · Traditional | Ciba Vision Corporation | 12/20/2001SE |
| K010559 | Sauflon Multi Lens Care SystemLPN · Traditional | Sauflon Pharmaceuticals, Ltd. | 12/20/2001SE |
| K011561 | Sereine Extra Strength Daily CleanerLPN · Traditional | Wilsa, Inc. | 11/20/2001SE |
| K011796 | Renu Multiplus No Rub Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 11/01/2001SE |
| K003345 | Aosept Plus Cleaning and Disinfecting SolutionLPN · Traditional | Ciba Vision Corporation | 03/26/2001SE |
| K003252 | Complete Brand Multi-Purpose SolutionLPN · Traditional | Allergan, Inc. | 02/21/2001SE |
| K003031 | Lensoclean Multi-Purpose Solution, Model 355MLLPN · Traditional | Alpha Vista, Inc. | 01/05/2001SE |
| K003109 | Complete Brand Lubricating and Rewetting DropsLPN · Abbreviated | Allergan, Inc. | 11/21/2000SE |
| K002589 | Opti-Free Express Multi-Purpose Disinfecting SolutionLPN · Traditional | Alcon Universal, Ltd. | 10/23/2000SE |
| K002823 | Renu Multiplus Multi-Purpose Disinfecting SolutionLPN · Traditional | Bausch & Lomb, Inc. | 10/17/2000SE |
| K002319 | Purilens Saline SolutionLPN · Traditional | Purilens, Inc. | 08/30/2000SE |
| K001539 | Renu Multiplus Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 07/31/2000SE |
| K001214 | Opti-Free Express Multi-Purpose Disinfecting SolutionLPN · Traditional | Alcon Universal, Ltd. | 07/10/2000SE |
| K000998 | Option Care System for the Cleaning and Disinfecting of Soft (Hydrophilic) Contact LensesLPN · Traditional | Optisonic, Inc. | 06/05/2000SE |
| K000164 | Complete Brand Comfortplus Multi-Purpose SolutionLPN · Traditional | Allergan, Inc. | 06/02/2000SE |
| K000247 | Bausch & Lomb Renu 1 Step Daily Protein RemoverLPN · Traditional | Bausch & Lomb, Inc. | 04/20/2000SE |
| K992028 | Refresh Contacts Lubricating and Rewetting DropsLPN · Abbreviated | Allergan, Inc. | 10/07/1999SE |
| K991620 | Visine for ContactsLPN · Traditional | Pfizer, Inc. | 09/24/1999SE |
| K984573 | Opti-Free Express Multi-Action Cleaning and Rewetting DropLPN · Traditional | Alcon Laboratories | 09/16/1999SE |
| K991125 | Sauflon Aerotab Disinfecting System for the Disinfection of Soft (Hydrophilic) Contact…LPN · Traditional | Sauflon Pharmaceuticals, Ltd. | 09/14/1999SE |
| K991403 | Solo-Care Brand Multi-Purpose SolutionLPN · Traditional | Ciba Vision Corporation | 07/16/1999SE |
| K990480 | Opti-Free Supraclens Daily Protein RemoverLPN · Traditional | Alcon Laboratories | 05/10/1999SE |
| K990422 | Renu Multiplus Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 04/27/1999SE |
| K983225 | Bausch & Lomb Renu Effervescent Enzymatic Contact Lens CleanerLPN · Traditional | Bausch & Lomb, Inc. | 03/29/1999SE |
| K990044 | Lobob Universal Contact Lens CleanerLPN · Traditional | Lobob Laboratories, Inc. | 02/11/1999SE |
| K984575 | Multi-Purpose Disinfecting Solution Id 90746LPN · Special | Alcon Laboratories | 01/14/1999SE |
| K984383 | Ultracare Neutralizing TabletsLPN · Special | Allergan, Inc. | 12/18/1998SE |
| K983973 | Opti-One Multi-Purpose SolutionLPN · Traditional | Alcon Laboratories | 12/18/1998SE |
| K983780 | Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | Alcon Laboratories | 12/18/1998SE |
| K983150 | Complete Brand Lubricating and Rewetting DropsLPN · Traditional | Allergan, Inc. | 11/25/1998SE |
| K982168 | Solo-Care Brand Multi-Purpose SolutionLPN · Traditional | Ciba Vision Corporation | 11/17/1998SE |
| K982775 | Bausch & Lomb Renu Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 11/03/1998SE |
| K981168 | Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting DropsLPN · Traditional | Allergan, Inc. | 09/01/1998SE |
| K981561 | Liquid Enzyme Id 90133LPN · Traditional | Alcon Laboratories | 07/24/1998SE |
| K981574 | Opti-Free Express Multi-Purpose SolutionLPN · Traditional | Alcon | 07/06/1998SE |
| K980775 | Complete Brand Multi-Purpose SolutionLPN · Traditional | Allergan, Inc. | 07/06/1998SE |
| K980591 | Renu Multiplus Lubricating & Rewetting DropsLPN · Traditional | Bausch & Lomb, Inc. | 06/24/1998SE |
| K981151 | Opti-Free Supraclens Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and…LPN · Traditional | Alcon Laboratories | 06/22/1998SE |
| K980147 | Your Choice Multi-Purpose Contact Lens Cleaning SolutionLPN · Traditional | Automatic Liquid Packaging, Inc. | 04/13/1998SE |
| K980133 | Bausch & Lomb Wetting and Soaking SolutionLPN · Traditional | Polymer Technology Corp. | 03/11/1998SE |
| K974723 | Renu Multiplus Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 03/10/1998SE |
| K974625 | Opti-Free Supraclens Daily Protein RemoverLPN · Traditional | Alcon Laboratories | 03/04/1998SE |
| K974624 | Alcon Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | Alcon Laboratories | 03/04/1998SE |
| K974485 | Sauflon All-In-One Light Contact Lens SolutionLPN · Traditional | Szabocsik and Assoc. | 02/24/1998SE |
| K973921 | Bausch & LOMB2 Sensitive Eyes Multi-Purpose SolutionLPN · Traditional | Bausch & Lomb, Inc. | 01/12/1998SE |
| K973332 | Alcon Multi-Purpose Disinfecting Solution Id 90746LPN · Traditional | Alcon Laboratories | 12/02/1997SE |
| K973217 | Boston Liquid Enzymatic CleanerLPN · Traditional | Polymer Technology Corp. | 11/24/1997SE |
| K923438 | Boston Conditioning SolutionLPN · Traditional | Polymer Technology Corp. | 12/28/1992SE |
| K923437 | Boston Cleaner IILPN · Traditional | Polymer Technology Corp. | 10/28/1992SE |
| K914483 | Wetting Solution for Hard Contact LensesLPN · Traditional | Optopics Laboratories Corp. | 02/05/1992SE |
| K890303 | Opti-Tears(R)LPN · Traditional | Alcon Laboratories | 02/17/1989SE |
| K880688 | SLC Hard Lens CleanerLPN · Traditional | Ocular Pharmaceuticals, Inc. | 06/28/1988SE |
| K881987 | Duraclean Daily CleanerLPN · Traditional | Allergan Optical | 06/09/1988SE |
| K874364 | Bausch & Lomb Renu Rewetting & Lubricating DropsLPN · Traditional | Bausch & Lomb, Inc. | 11/25/1987SE |
| K872973 | W-J Sterile Tri-Functional Contact Lens SolutionLPN · Traditional | Wesley Jessen Corp. | 10/15/1987SE |
| K873548 | Opti-Zyme(R)LPN · Traditional | Alcon Laboratories | 09/29/1987SE |
| K872164 | RestoreLPN · Traditional | Anderson Research, Inc. | 09/17/1987SE |
| K871714 | Kestrel Contact Lens CaseLPN · Traditional | Applied Laboratories, Inc. | 05/26/1987SE |
| K863846 | Contac CaseLPN · Traditional | S. M. C. Medi-Tech Corp. | 04/06/1987SE |
| K863346 | Professional Disinfection System (PDS)LPN · Traditional | Ciba Vision Care | 02/27/1987SE |
| K870278 | Contact Lens Case W/Postive Heat Indi. Mod. #695LPN · Traditional | Ryder Intl. Corp. | 02/20/1987SE |
| K864502 | The Contact Lens Assist BrushLPN · Traditional | Young and Moore Enterprises, Inc. | 01/20/1987SE |
| K864157 | Opti-BrushLPN · Traditional | Willmar Contact Lens Clinic | 11/13/1986SE |
| K843511 | Bausch & Lomb Cleaning PadLPN · Traditional | Bausch & Lomb, Inc. | 10/16/1986SE |
| K852386 | Soft Mate Automatic Contact Lens Cleaning UnitLPN · Traditional | Barnes-Hind, Inc. | 09/04/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1540-2022 Class II | OPTI FREE REPLENISH MULTI PURPOSE 2 OZAffected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1533-2022 Class II | CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1531-2022 Class II | B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1590-2022 Class II | a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number:…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0948-2021 Class II | REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileMissing Instruction For Use insert. | Allergan PLC | 12/29/2020Terminated |
| Z-0651-2017 Class II | PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack…Product was found to contain excess residual levels of hydrogen peroxide. | Bausch & Lomb Inc Irb | 09/19/2016Terminated |
| Z-1557-2011 | AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed…Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico. | Marietta Vision | 02/21/2011Terminated |
| Z-0130-2011 | AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml).…The recall was initiated after AMO determined, through internal testing, that a limited number of the flip… | Abbott Medical Optics Inc (AMO) | 07/23/2010Terminated |
| Z-0129-2011 | AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505…The recall was initiated after AMO determined, through internal testing, that a limited number of the flip… | Abbott Medical Optics Inc (AMO) | 07/23/2010Terminated |
| Z-0159-2010 | Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb…During routine testing the product failed to meet shelf life specifications. | Bausch & Lomb Inc | 08/17/2009Terminated |
| Z-1735-2009 | Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable…The product failed to meet one of the shelf life specifications at the end of the expiry period. | Bausch & Lomb Inc | 06/30/2009Terminated |
| Z-1093-2007 | COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product…In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention… | Advanced Medical Optics, Inc. | 05/25/2007Terminated |
| Z-1092-2007 | COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; (A) Fourteen US Product…In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention… | Advanced Medical Optics, Inc. | 05/25/2007Terminated |
| Z-0348-2007 | Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding…Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have… | Advanced Medical Optics, Inc. | 09/15/2006Terminated |
| Z-0347-2007 | Complete Blink N Clean (US and Asia Pacific markets)Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have… | Advanced Medical Optics, Inc. | 09/15/2006Terminated |
| Z-0346-2007 | COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and…Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have… | Advanced Medical Optics, Inc. | 09/15/2006Terminated |
| Z-0345-2007 | Krystal Klear Rinse (China only)Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have… | Advanced Medical Optics, Inc. | 09/15/2006Terminated |
| Z-0344-2007 | COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding…Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have… | Advanced Medical Optics, Inc. | 09/15/2006Terminated |