Isotechnics
1,008 catalogue numbers from UC55A-05.5, listed by Eyekon Medical, Inc., United States, under Intraocular Lens. 1 manufacturer in China is registered for this product code.
1manufacturer
1,008catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Vision PRO Ltd | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Eyekon Medical, Inc., United States |
|---|---|
| FDA product code | HQL |
| Device type | Intraocular Lens |
| Device class | Class 3 |
| Regulation | 21 CFR 886.3600 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P880072 |
| Record published | 2015-09-18 |
| Record revised | 2021-07-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UC55A-05.5 | In distribution | |
| U600C-2P-06.5 | In distribution | |
| U600C-2P-10.0 | In distribution | |
| U600C-2P-11.5 | In distribution | |
| UJ65D-2P-11.5 | In distribution | |
| UL600S-11.0 | In distribution | |
| UCN5-B-06.0 | In distribution | |
| UC65B-21.5 | In distribution | |
| UL600S-14.0 | In distribution | |
| U615B-18.0 | In distribution | |
| U500C-13.5 | In distribution | |
| UL600S-26.0 | In distribution | |
| U400D-2P-25.0 | In distribution | |
| U600C-25.0 | In distribution | |
| UC120-05.5 | In distribution | |
| UC55A-09.0 | In distribution | |
| UG55B-30.0 | In distribution | |
| U600C-29.5 | In distribution | |
| U615B-04.5 | In distribution | |
| U500C-14.0 | In distribution | |
| U600C-2P-27.5 | In distribution | |
| UN50A-20.0 | In distribution | |
| UJ65D-2P-13.5 | In distribution | |
| UC55B-15.0 | In distribution | |
| UC65B-26.5 | In distribution | |
| UG55B-29.0 | In distribution | |
| U600B-16.0 | In distribution | |
| UC55B-06.0 | In distribution | |
| U600B-2P-20.5 | In distribution | |
| U615B-10.5 | In distribution | |
| U512B-04.5 | In distribution | |
| U500C-21.5 | In distribution | |
| U600B-2P-25.5 | In distribution | |
| UL600S-13.0 | In distribution | |
| UN50A-21.0 | In distribution | |
| U600B-29.5 | In distribution | |
| UC55B-24.5 | In distribution | |
| U400D-05.5 | In distribution | |
| UN50A-09.5 | In distribution | |
| U400D-2P-06.5 | In distribution | |
| U615B-28.5 | In distribution | |
| UC65B-11.5 | In distribution | |
| UL50A-08.0 | In distribution | |
| U615B-12.0 | In distribution | |
| UC65B-04.0 | In distribution | |
| U600B-18.5 | In distribution | |
| U600B-2P-29.5 | In distribution | |
| U500C-29.0 | In distribution | |
| UL600S-25.5 | In distribution | |
| UCN5-B-20.5 | In distribution | |
| UC55B-12.0 | In distribution | |
| U600B-2P-28.5 | In distribution | |
| U615B-22.5 | In distribution | |
| UC55A-12.5 | In distribution | |
| UC55A-24.0 | In distribution | |
| UC65B-15.0 | In distribution | |
| UN50A-07.0 | In distribution | |
| U600B-12.0 | In distribution | |
| U600C-2P-23.0 | In distribution | |
| U600B-10.5 | In distribution | |
| U500C-23.0 | In distribution | |
| UC120-11.5 | In distribution | |
| U500C-16.5 | In distribution | |
| U615B-09.5 | In distribution | |
| UC120-06.5 | In distribution | |
| U400D-2P-28.0 | In distribution | |
| U615B-16.0 | In distribution | |
| U600C-2P-28.0 | In distribution | |
| U615B-21.0 | In distribution | |
| U500C-20.5 | In distribution | |
| UN50A-09.0 | In distribution | |
| U615B-07.5 | In distribution | |
| U400D-2P-06.0 | In distribution | |
| UG55B-12.0 | In distribution | |
| UN50A-10.5 | In distribution | |
| UL50A-15.5 | In distribution | |
| U400D-14.5 | In distribution | |
| UJ65D-2P-18.0 | In distribution | |
| UC55A-04.0 | In distribution | |
| U500C-20.0 | In distribution | |
| UJ65D-2P-04.0 | In distribution | |
| U600B-06.0 | In distribution | |
| UC55B-28.5 | In distribution | |
| UC55B-14.0 | In distribution | |
| UC55A-17.5 | In distribution | |
| UN50A-26.5 | In distribution | |
| U400D-10.5 | In distribution | |
| UC65B-25.0 | In distribution | |
| U512B-24.0 | In distribution | |
| U400D-2P-18.5 | In distribution | |
| UJ65D-2P-09.5 | In distribution | |
| UG55B-11.0 | In distribution | |
| U512B-04.0 | In distribution | |
| UCN5-B-08.0 | In distribution | |
| UL600S-29.0 | In distribution | |
| U600B-09.0 | In distribution | |
| UN50A-14.5 | In distribution | |
| U600B-2P-22.0 | In distribution | |
| UC55A-10.0 | In distribution | |
| UL50A-26.5 | In distribution | |
| UC120-13.5 | In distribution | |
| U512B-21.5 | In distribution | |
| U512B-16.0 | In distribution | |
| UN50A-18.5 | In distribution | |
| UN50A-28.0 | In distribution | |
| U500C-07.5 | In distribution | |
| UC55B-07.5 | In distribution | |
| UG55B-06.5 | In distribution | |
| U512B-05.0 | In distribution | |
| U512B-19.5 | In distribution | |
| UN50A-05.5 | In distribution | |
| UG55B-23.5 | In distribution | |
| U600C-2P-07.5 | In distribution | |
| UL50A-07.0 | In distribution | |
| U400D-2P-11.0 | In distribution | |
| U600C-2P-12.0 | In distribution | |
| U615B-13.0 | In distribution | |
| UG55B-07.0 | In distribution | |
| UN50A-17.0 | In distribution | |
| U600B-2P-12.0 | In distribution | |
| U600C-2P-08.5 | In distribution | |
| U600B-2P-28.0 | In distribution | |
| U600C-2P-22.5 | In distribution | |
| UC65B-13.0 | In distribution | |
| UC65B-05.0 | In distribution | |
| UCN5-B-16.5 | In distribution | |
| UL600S-18.0 | In distribution | |
| UCN5-B-04.0 | In distribution | |
| UG55B-24.0 | In distribution | |
| UN50A-08.0 | In distribution | |
| UL50A-10.0 | In distribution | |
| U600C-05.5 | In distribution | |
| UC120-16.0 | In distribution | |
| U400D-20.5 | In distribution | |
| UC55B-25.0 | In distribution | |
| U615B-20.0 | In distribution | |
| UL50A-25.0 | In distribution | |
| UC55A-13.0 | In distribution | |
| UJ65D-2P-22.5 | In distribution | |
| UN50A-27.5 | In distribution | |
| UG55B-04.0 | In distribution | |
| U600C-12.5 | In distribution | |
| UC65B-06.0 | In distribution | |
| U512B-15.5 | In distribution | |
| UL600S-22.0 | In distribution | |
| UJ65D-2P-26.5 | In distribution | |
| UC120-30.0 | In distribution | |
| UG55B-16.0 | In distribution | |
| U600B-17.5 | In distribution | |
| UL50A-30.0 | In distribution | |
| U500C-16.0 | In distribution | |
| UCN5-B-17.0 | In distribution | |
| U600C-26.0 | In distribution | |
| U600B-21.5 | In distribution | |
| UN50A-13.5 | In distribution | |
| U600B-15.0 | In distribution | |
| U600B-23.0 | In distribution | |
| U615B-14.5 | In distribution | |
| UN50A-29.5 | In distribution | |
| UC55B-26.0 | In distribution | |
| UJ65D-2P-08.5 | In distribution | |
| UCN5-B-07.5 | In distribution | |
| U600B-25.5 | In distribution | |
| UG55B-20.0 | In distribution | |
| U500C-27.5 | In distribution | |
| UC55A-23.5 | In distribution | |
| UCN5-B-12.5 | In distribution | |
| UC55A-21.5 | In distribution | |
| U600C-2P-30.0 | In distribution | |
| UC55B-15.5 | In distribution | |
| U600C-15.5 | In distribution | |
| UC120-18.5 | In distribution | |
| U500C-09.0 | In distribution | |
| UN50A-23.5 | In distribution | |
| UL600S-16.5 | In distribution | |
| U615B-18.5 | In distribution | |
| UG55B-13.5 | In distribution | |
| U500C-04.0 | In distribution | |
| UCN5-B-05.0 | In distribution | |
| UC65B-27.5 | In distribution | |
| U512B-13.0 | In distribution | |
| U600C-2P-24.0 | In distribution | |
| UC65B-10.0 | In distribution | |
| U500C-13.0 | In distribution | |
| U512B-20.0 | In distribution | |
| U400D-2P-29.5 | In distribution | |
| U600C-2P-11.0 | In distribution | |
| UC55B-10.0 | In distribution | |
| UC55B-11.5 | In distribution | |
| UL50A-24.5 | In distribution | |
| UCN5-B-25.0 | In distribution | |
| UC55B-18.0 | In distribution | |
| UC120-21.5 | In distribution | |
| U400D-26.5 | In distribution | |
| U600B-2P-07.5 | In distribution | |
| U512B-14.0 | In distribution | |
| U400D-13.5 | In distribution | |
| U600C-07.5 | In distribution | |
| UL50A-21.5 | In distribution | |
| UL600S-25.0 | In distribution | |
| U600C-24.5 | In distribution | |
| UJ65D-2P-23.0 | In distribution | |
| UL50A-29.5 | In distribution | |
| UC55A-20.5 | In distribution | |
| UC120-25.5 | In distribution | |
| U600C-09.0 | In distribution | |
| U600B-2P-11.0 | In distribution | |
| U615B-25.5 | In distribution | |
| U615B-22.0 | In distribution | |
| UC55B-27.0 | In distribution | |
| UJ65D-2P-12.0 | In distribution | |
| UC120-09.5 | In distribution | |
| U600B-2P-04.0 | In distribution | |
| U400D-2P-20.5 | In distribution | |
| U600B-20.0 | In distribution | |
| UCN5-B-09.0 | In distribution | |
| UJ65D-2P-10.5 | In distribution | |
| UC120-28.0 | In distribution | |
| U400D-2P-19.5 | In distribution | |
| UC120-08.0 | In distribution | |
| U512B-23.5 | In distribution | |
| U600B-09.5 | In distribution | |
| U400D-07.5 | In distribution | |
| UC120-05.0 | In distribution | |
| U400D-15.5 | In distribution | |
| U512B-21.0 | In distribution | |
| U400D-22.0 | In distribution | |
| UN50A-22.0 | In distribution | |
| UCN5-B-28.0 | In distribution | |
| UC55A-28.5 | In distribution | |
| UL600S-21.0 | In distribution | |
| UG55B-10.5 | In distribution | |
| UN50A-30.0 | In distribution | |
| U600B-26.0 | In distribution | |
| UC120-11.0 | In distribution | |
| U615B-06.5 | In distribution | |
| U600C-2P-26.0 | In distribution | |
| U600B-2P-14.0 | In distribution | |
| UL50A-12.5 | In distribution | |
| U400D-23.0 | In distribution | |
| UJ65D-2P-21.5 | In distribution | |
| U600C-2P-25.5 | In distribution | |
| U600C-04.5 | In distribution | |
| UC120-17.0 | In distribution | |
| UC65B-14.5 | In distribution | |
| U512B-08.0 | In distribution | |
| U615B-29.5 | In distribution | |
| UG55B-08.0 | In distribution | |
| U512B-30.0 | In distribution | |
| UG55B-15.5 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clareon | Alcon Laboratories, Inc. | 1,760 |
| enVista® Toric IOL | Bausch & Lomb Incorporated | 1,274 |
| AcrySof® | Alcon Laboratories, Inc. | 1,223 |
| EnVista MX60 IOL | Bausch & Lomb Incorporated | 1,050 |
| MDR | Eyekon Medical, Inc. | 1,007 |
| DGR | Eyekon Medical, Inc. | 1,007 |
| Acuity | Eyekon Medical, Inc. | 1,007 |
| Acurus | Eyekon Medical, Inc. | 901 |
| Cirrus | Eyekon Medical, Inc. | 901 |
| Eyekon | Eyekon Medical, Inc. | 901 |
| enVista Aspire™ Toric IOL | Bausch & Lomb Incorporated | 798 |
| Suncoast | Eyekon Medical, Inc. | 795 |
Showing 12 of 71. All products under Intraocular Lens
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P190018 | 2026-07-06 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | Alcon Laboratories, Inc. |
| P240038 | 2025-09-10 | FINEVISION HP Trifocal IOLs | Beaver-Visitec International, Ltd |
| P930014 | 2023-10-24 | AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems | Alcon Laboratories, Inc. |
| P100016 | 2023-01-05 | CT LUCIA Intraocular Lens (IOL) | Carl Zeiss Meditec Production, LLC. |
| P060011 | 2019-04-12 | Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses | Rayner Intraocular Lenses Limited |
| P060022 | 2018-08-07 | Akreos Intraocular Lens | Bausch & Lomb Incorporated |
| P910056 | 2012-10-19 | EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS | Bausch & Lomb Incorporated |
| P090022 | 2012-09-20 | LENSTEC SOFTEC HD PCIOL | Lenstec, Inc. |
| P990080 | 2012-05-23 | TECNIS MULTIFOCAL INTRAOCULAR LENS, MODEL ZMA00 | Johnson & Johnson Surgical Vision, Inc. |
| P880081 | 2012-04-23 | AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL) | Johnson & Johnson Surgical Vision, Inc. |
| P080004 | 2012-01-20 | BIOLOGICAL INDICATOR (BI) | Hoya Surgical Optics, Inc. |
| P810032 | 2011-07-21 | ACRYSOF RESTOR INTRAOCULAR LENSES | Alcon Laboratories, Inc. |
| P840060 | 2010-06-02 | PMMA INTRAOCULAR LENSES | Alcon Laboratories, Inc. |
| P010027 | 2010-03-12 | ANTERIOR CHAMBER INTRAOCULAR LENS | Aaren Scientific Inc |
| P080021 | 2009-02-02 | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Bausch & Lomb Incorporated |
| P980040 | 2007-03-22 | AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS) | Johnson & Johnson Surgical Vision, Inc. |
| P990013 | 2007-03-22 | STAAR SURGICAL COLLAMER INTRAOCULAR LENSES | Starr Surgical Co. |
| P880091 | 2005-10-19 | ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL | Staar Surgical Company |
| P880087 | 2005-03-04 | PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES | Alcon Laboratories, Inc. |
| P880070 | 2005-02-04 | CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) | Abbott Medical Optics, Inc. |
| P990014 | 2003-09-16 | HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL) | Bausch & Lomb Incorporated |
| P910058 | 2003-08-13 | SILICONE INTRAOCULAR LENSES | Bausch & Lomb Incorporated |
| P910061 | 2003-07-23 | BIOBURDEN TESTING | Bausch & Lomb Incorporated |
| P970034 | 1998-09-25 | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES | Aaren Scientific Inc |
| P800049 | 1998-09-04 | IRIDOCAPSULAR INTRAOCULAR LENS | Alcon, Inc. |
| P960036 | 1997-12-22 | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) | Ioltech, S.A. |
| P890056 | 1997-10-02 | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS | Advanced Medical Optics, Inc. |
| P940007 | 1996-12-10 | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920) | Advanced Medical Optics, Inc. |
| P880072 | 1996-04-17 | MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Eyekon Medical, Inc. |
| P830056 | 1996-04-02 | POSTERIOR CHAMBER INTROCULAR LENSES | Carl Zeiss Meditec Inc |
| P810055 | 1994-08-23 | CM(TM) LENSES | Advanced Medical Optics, Inc. |
| P910060 | 1994-04-20 | ELASTIMIDE(TM) IOL MODEL AQ-2010 | Staar Surgical Company |
| P840039 | 1994-03-28 | J-LOOP POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb Incorporated |
| P900048 | 1993-08-23 | ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM | Staar Surgical Company |
| P860034 | 1992-11-09 | MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL | Advanced Medical Optics, Inc. |
| P840033 | 1992-05-29 | MODELS KR2V, SK21V, S2BV | Alcon Laboratories, Inc. |
| P820016 | 1991-12-20 | ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING | Cilco, Inc. |
| P880085 | 1991-06-27 | MODEL 405 SPANFLEX TM IOL | Advanced Medical Optics, Inc. |
| P900037 | 1991-02-28 | MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS | Medical Development Research, Inc. |
| P900053 | 1991-02-28 | MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR | Vision Medical Inc |
| P860002 | 1990-11-15 | COBURN(R) POSTERIOR INTRAOCULAR LENSES | Bausch & Lomb Incorporated |
| P880090 | 1990-07-03 | MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb Incorporated |
| P880082 | 1990-06-26 | MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES | Eyetech, LLC |
| P870045 | 1990-03-29 | UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENES | Bausch & Lomb Incorporated |
| P820044 | 1990-03-19 | MODEL 91-50 IOL | Bausch & Lomb Incorporated |
| P880010 | 1990-01-16 | INTRAOCULAR LENS MODELS C118;C119;C138 AND C139 | Alcon Laboratories, Inc. |
| P890068 | 1990-01-11 | MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL | Chiron Ophthalmics |
| P850059 | 1989-12-11 | KELMAN(TM) OMNIFIT II MODEL 2100 | Bausch & Lomb Surgical, Inc. |
| P790027 | 1989-12-11 | CHAMBER LENS MODELS G187G, G786B, G787B | Bausch & Lomb Incorporated |
| P870075 | 1989-12-06 | CLASSIC SERIES TM POSTERIOR CHAMBER INTRAOCULAR | Newlensco |
| P870073 | 1989-11-30 | STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES | Bausch & Lomb Incorporated |
| P820072 | 1989-11-20 | CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC | Bausch & Lomb Incorporated |
| P830040 | 1989-10-10 | 8TYLES 30 & 31 POSTERIOR CHAMBER IOLS | Alcon Research, LLC |
| P860059 | 1989-02-21 | MODEL 304 (ULTRA C-LOOP) | Advanced Medical Optics, Inc. |
| P820049 | 1988-04-27 | MODELS PC10 & PC21 | Advanced Medical Optics, Inc. |
| P870013 | 1988-03-31 | IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR | Bausch & Lomb Incorporated |
| P810056 | 1987-12-07 | MODEL AC10 & AC20 IOLS | Advanced Medical Optics, Inc. |
| P820035 | 1987-11-03 | OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) | Alcon, Inc. |
| P800017 | 1987-09-21 | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS | Storz Ophthalmics, Inc. |
| P810018 | 1986-09-29 | POSTERIOR CHAMBER INTRAOCULAR LENSES | Alcon Laboratories, Inc. |
| P810001 | 1986-09-29 | MODEL AC (AC1-AC5) | Alcon, Inc. |
| P830033 | 1985-11-25 | STYLE 17 & 17A POSTERIOR CHAMBER IOLS | Advanced Vision Science, Inc. |
| P810042 | 1982-12-15 | MODELS 011 & 011B IRIDOCAPSULAR IOLS | Pharmacia, Inc. |
| P800027 | 1982-07-26 | BINKHORST & FEDOROV I IRIS CLIP IOLS | Storz Ophthalmics, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.