Part 886 Subpart D—Prosthetic Devices
FDA submissions for Part 886 Subpart D—Prosthetic Devices in the Ophthalmic (OP) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 886.3100–886.3920
CFR Part: 886
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HQW | Clip, Tantalum, Ophthalmic | 886.3100 | 2 | 3 |
| HQN | Conformer, Ophthalmic | 886.3130 | 2 | 7 |
| NQB | Conformer, Ophthalmic, Biological Tissue | 886.3130 | 2 | 1 |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | 886.3130 | 2 | 2 |
| QWU | Prosthesis, Eyelid Spacer/Graft, Polymer | 886.3130 | 2 | 1 |
| HQH | Eye, Artificial, Non-Custom | 886.3200 | 1 | 6 |
| NCK | Button, Iris, Eye, Artificial | 886.3200 | 1 | 1 |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) | 886.3300 | 2 | 5 |
| HPZ | Implant, Eye Sphere | 886.3320 | 2 | 39 |
| MQU | Ocular Peg | 886.3320 | 2 | 4 |
| MTZ | Wrap, Implant, Orbital | 886.3320 | 2 | 2 |
| NFM | Expander, Tissue, Orbital | 886.3320 | 2 | 2 |
| PUF | Ocular Peg, Exempt | 886.3320 | 2 | 0 |
| HQX | Implant, Orbital, Extra-Ocular | 886.3340 | 2 | 16 |
| HQM | Keratoprosthesis, Permanent Implant | 886.3400 | 2 | 4 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 886.3400 | 2 | 4 |
| HQL | Intraocular Lens | 886.3600 | 3 | 65 |
| MFK | Lens, Multifocal Intraocular | 886.3600 | 3 | 5 |
| MJP | Lens, Intraocular, Toric Optics | 886.3600 | 3 | 0 |
| NAA | Lens, Intraocular, Accommodative | 886.3600 | 3 | 1 |
| NIZ | Lens, Iris Reconstruction | 886.3600 | 3 | 0 |
| POE | Extended Depth Of Focus Intraocular Lens | 886.3600 | 3 | 1 |
| PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | 886.3600 | 3 | 1 |
| QCB | Phakic Toric Intraocular Lens | 886.3600 | 3 | 0 |
| HQT | Shell, Scleral | 886.3800 | 2 | 4 |
| KYF | Implant, Eye Valve | 886.3920 | 2 | 25 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| P240038 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Sep 10, 2025 |
| P240005 | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | Oct 10, 2024 |
| K223074 | CorNeat EverPatch | Corneat Vision , Ltd. | Jun 2, 2023 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | May 12, 2023 |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | May 12, 2023 |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | Aug 2, 2022 |
| P210005 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | Jul 22, 2022 |
| P200020 | SBL-3 Multifocal Intraocular Lens | Lenstec, Inc. | Jul 22, 2022 |
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | Jun 24, 2022 |
| P190018 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | Alcon Laboratories, LLC | Jan 7, 2020 |
| K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | Jan 30, 2019 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | Jan 18, 2019 |
| P160055 | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | Rxsight, Inc. | Nov 22, 2017 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | Aug 8, 2017 |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | Nov 21, 2016 |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | Oct 24, 2016 |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | Dec 17, 2015 |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | May 10, 2013 |
| K123764 | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | Jan 31, 2013 |
| K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | Nov 2, 2011 |
| K112176 | SILICONE SPHERES | Oculo Plastik, Inc. | Sep 15, 2011 |
| P100016 | EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL | Carl Zeiss Meditec Production, LLC | Oct 19, 2010 |
| P090022 | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS | Lenstec, Inc. | Apr 12, 2010 |
| K090078 | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | Iop, Inc. | May 8, 2009 |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | Mar 12, 2009 |
| K082850 | EYE SPHERES | Product and Educational Services, LLC | Feb 27, 2009 |
| P080021 | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Bausch & Lomb, Incorporated | Feb 2, 2009 |
| P080010 | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Johnson & Johnson Surgical Vision, Inc. | Jan 16, 2009 |
| P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | Hoya Surgical Optics, Inc. | Sep 26, 2008 |
| P060022 | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | Bausch & Lomb, Inc. | Sep 5, 2008 |
| K073293 | DURETTE IMPLANT | Oculo Plastik, Inc. | Mar 19, 2008 |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | Aug 8, 2007 |
| P060011 | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) | Rayner Intraocular Lenses , Ltd. | May 3, 2007 |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | Apr 19, 2007 |
| K062252 | MOLTENO3 | Iop, Inc. | Sep 27, 2006 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | Sep 18, 2006 |
| K060151 | ORBITAL TISSUE EXPANDER (OTE) | Innovia, LLC | Aug 8, 2006 |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | May 9, 2006 |
| K053622 | SURGISIS OCULAR GRAFT | Iop, Inc. | Mar 15, 2006 |
| P040020 | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | Alcon Research, Ltd. | Mar 21, 2005 |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | Jul 16, 2004 |
| K040689 | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | Jun 10, 2004 |
| K032104 | AMNIOLENS | Bio-Tissue, Inc. | Dec 12, 2003 |
| P030002 | CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Bausch & Lomb, Inc. | Nov 14, 2003 |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Aug 22, 2003 |
| K030350 | EXPRESS MINI GLAUCOMA SHUNT | Optonol, Ltd. | Mar 13, 2003 |
| K023643 | MACROPORE SURGICAL BARRIER FILM | Macropore Biosurgery, Inc. | Feb 21, 2003 |
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | Jan 8, 2003 |
| K021643 | HA ORBITAL IMPLANT | Laboratoire Villanova | Dec 13, 2002 |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | Aug 29, 2002 |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | Aug 5, 2002 |
| K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | Optonol, Ltd. | Mar 26, 2002 |
| P010027 | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) | Aaren Scientific | Nov 21, 2001 |
| K010852 | OSMED TISSUE EXPANDER | Iop, Inc. | Aug 13, 2001 |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | Jun 19, 2001 |
| P990080 | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | Johnson & Johnson Surgical Vision, Inc. | Apr 5, 2001 |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | Feb 7, 2001 |
| K001326 | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON | Ocular Concepts, LLC | Jun 13, 2000 |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Apr 19, 2000 |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | Apr 10, 2000 |
| P990013 | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Starr Surgical Co. | Apr 2, 2000 |
| P980040 | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Feb 3, 2000 |
| P990014 | HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | Nov 12, 1999 |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | Jul 13, 1999 |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | Dec 28, 1998 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | Nov 6, 1998 |
| P970034 | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES | Aaren Scientific | Sep 25, 1998 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | Sep 18, 1998 |
| K980822 | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | Jul 9, 1998 |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | Apr 20, 1998 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | Feb 4, 1998 |
| K972034 | MEDPOR OCULAR CONFORMER | Porex Surgical, Inc. | Jan 20, 1998 |
| P960036 | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) | Ioltech, S.A. | Dec 22, 1997 |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Bio-Vascular, Inc. | Dec 16, 1997 |
| K972143 | MOA BONE / M-SPHERE | Iop, Inc. | Oct 16, 1997 |
| K972661 | EYE SPHERE, CONFORMERS | Gulden Ophthalmics | Oct 3, 1997 |
| P960028 | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Sep 5, 1997 |
| K970327 | SCLERAL SHELL | Southwest Artificial Eyes, Inc. | Jul 7, 1997 |
| K970320 | SCLERAL SHELL | Xavier A. Guerra, Ocularist, Inc. | Jul 7, 1997 |
| K970319 | OCULAR CONFORMER | Xavier A. Guerra, Ocularist, Inc. | Jul 7, 1997 |
| K970318 | OCULAR CONFORMER | Southwest Artificial Eyes, Inc. | Jul 7, 1997 |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | Jun 30, 1997 |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | Feb 18, 1997 |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | Oct 28, 1996 |
| K962241 | GORE SPHEREX IMPLANT | W. L. Gore & Associates, Inc. | Aug 22, 1996 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | Jun 5, 1996 |
| K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES | Porex Technologies Corp. of Georgia | May 29, 1996 |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | Porex Surgical, Inc. | Jan 25, 1996 |
| P940007 | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL | Advanced Medical Optics, Inc. | Jul 20, 1995 |
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | Jun 26, 1995 |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | May 30, 1995 |
| K946226 | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | Mar 22, 1995 |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | Mar 2, 1995 |
| K941717 | MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT | Miguel Martinez M.D. | Feb 14, 1995 |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | Jan 17, 1995 |
| K945110 | KOLBERG OPHTHALMIC CONFORMER | Kolberg Ocular Products, Inc. | Jan 13, 1995 |
| P930014 | ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES | Alcon Laboratories, Inc. | Dec 22, 1994 |
| P910061 | MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS | Bausch & Lomb | Sep 2, 1994 |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | Porex Surgical, Inc. | Sep 2, 1994 |
| P890056 | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS | Advanced Medical Optics, Inc. | May 26, 1994 |
