Envista® IOL
enVista one-piece hydrophobic acrylic intraocular lens (preloaded) +17.50D
1manufacturer
166catalogue numbers in this listing
10recalls on this code
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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HQL |
| Device type | Intraocular Lens |
| Device class | Class 3 |
| Regulation | 21 CFR 886.3600 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-05-16 |
| Record revised | 2024-05-20 (version 5) |
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 |
|---|---|---|
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60E | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution | |
| MX60PL | In distribution | |
| MX60E | In distribution | |
| MX60PL | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| EE | In distribution | |
| MX60PL | In distribution |
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 |
| Isotechnics | Eyekon Medical, Inc. | 1,008 |
| 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 |
Showing 12 of 71. All products under Intraocular Lens
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-06 | Class III | Process control | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could resul | 2 | |
| 2025-03-27 | Class I | Process control | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S. | 236,840 | |
| 2020-06-09 | Class II | Unknown/Undetermined by firm | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. | 5 | 2021-02-11 |
| 2018-11-05 | Class II | Process control | Cosmetic imperfections on the surface of some lenses. | 70,440 units | 2019-11-04 |
| 2015-05-26 | Class II | Device Design | Haptics breaking during lens loading and insertion. | 72,773 units; 52,787 units (US) 19,986 units (Foreign) | 2016-08-25 |
| 2015-05-26 | Class II | Device Design | Haptics breaking during lens loading and insertion. | 72,773 units. 52,787 units (US) – 19,986 units (Foreign) | 2016-08-25 |
| 2013-10-16 | Class II | Nonconforming Material/Component | Lens was manufactured with incorrect raw material. | 336 IOLs (283 IOLs in the US, 53 IOLs outside the US) | 2014-09-17 |
| 2009-11-19 | Not classified | Other | Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occ | 85 lenses | 2010-07-22 |
| 2008-12-08 | Not classified | Release of Material/Component prior to receiving test results | Affected lenses were inadvertently shipped to Bausch & Lomb’s European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits. | 158 | 2009-11-05 |
| 2004-02-27 | Not classified | Other | Lens may be labeled with incorrect diopter size. | 36 | 2012-05-03 |
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.