EnVista MX60 IOL

MX60TP5.00 12.5MM +1.45

Registry build 21.09.26
1manufacturer
1,050catalogue numbers in this listing
10recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code HQL
Manufacturer City Province Registered as Device types
Wuxi Vision PRO Ltd Wuxi Jiangsu Manufacturer 1

Record

Regulatory record for EnVista MX60 IOL
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 2015-09-18
Record revised 2024-07-01 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries expiry date, serial number
Distribution end date 2024-06-27

Catalogue Numbers

Catalogue numbers for EnVista MX60 IOL
Catalogue number Size Status
MX60T500+115 Withdrawn
MX60T125+235 Withdrawn
MX60TP500+195 Withdrawn
MX60T300+155 Withdrawn
MX60T125+185 Withdrawn
MX60T500+145 Withdrawn
MX60TP425+100 Withdrawn
MX60T225+190 Withdrawn
MX60P2450 Withdrawn
MX60TP500+185 Withdrawn
MX60T425+125 Withdrawn
MX60TP200+170 Withdrawn
MX60USP2700 Withdrawn
MX60T150+080 Withdrawn
MX60A0400 Withdrawn
MX60T150+120 Withdrawn
MX60T275+065 Withdrawn
MX60T350+250 Withdrawn
MX60TP200+260 Withdrawn
MX60TP275+190 Withdrawn
MX60T350+200 Withdrawn
MX60T425+160 Withdrawn
MX60T300+160 Withdrawn
MX60TP125+225 Withdrawn
MX60TP275+170 Withdrawn
MX60TP500+285 Withdrawn
MX60US1450 Withdrawn
MX60T300+060 Withdrawn
MX60T575+130 Withdrawn
MX60T200+075 Withdrawn
MX60TP275+125 Withdrawn
MX60T150+170 Withdrawn
MX60T275+080 Withdrawn
MX60A2150 Withdrawn
MX60T500+125 Withdrawn
MX60T300+265 Withdrawn
MX60T350+195 Withdrawn
MX60T350+235 Withdrawn
MX60TP425+185 Withdrawn
MX60TP200+275 Withdrawn
MX60T350+210 Withdrawn
MX60TP500+100 Withdrawn
MX60TP125+205 Withdrawn
MX60TP500+265 Withdrawn
MX60T500+250 Withdrawn
MX60T300+120 Withdrawn
MX60TP500+225 Withdrawn
MX60TP350+250 Withdrawn
MX60T150+180 Withdrawn
MX60T300+165 Withdrawn
MX60TP200+235 Withdrawn
MX60T275+190 Withdrawn
MX60TP350+190 Withdrawn
MX60T275+215 Withdrawn
MX60US2550 Withdrawn
MX60A1200 Withdrawn
MX60USP1500 Withdrawn
MX60T275+210 Withdrawn
MX60T575+135 Withdrawn
MX60USP2450 Withdrawn
MX60T425+145 Withdrawn
MX60P1350 Withdrawn
MX60TP200+215 Withdrawn
MX60T225+260 Withdrawn
MX60T200+205 Withdrawn
MX60US2800 Withdrawn
MX60T500+215 Withdrawn
MX60TP575+120 Withdrawn
MX60TP425+260 Withdrawn
MX60TP125+290 Withdrawn
MX60T275+260 Withdrawn
MX60T575+185 Withdrawn
MX60T150+095 Withdrawn
MX60T225+155 Withdrawn
MX60P2550 Withdrawn
MX60T350+085 Withdrawn
MX60T350+080 Withdrawn
MX60T500+235 Withdrawn
MX60US1900 Withdrawn
MX60T200+170 Withdrawn
MX60US0200 Withdrawn
MX60TP425+105 Withdrawn
MX60T125+230 Withdrawn
MX60T575+285 Withdrawn
MX60TP350+075 Withdrawn
MX60T500+195 Withdrawn
MX60TP125+285 Withdrawn
MX60T275+140 Withdrawn
MX60TP350+235 Withdrawn
MX60T150+295 Withdrawn
MX60US1350 Withdrawn
MX60TP275+095 Withdrawn
MX60TP425+225 Withdrawn
MX60A2950 Withdrawn
MX60T225+200 Withdrawn
MX60T350+300 Withdrawn
MX60A3000 Withdrawn
MX60TP500+155 Withdrawn
MX60TP350+195 Withdrawn
MX60TP500+150 Withdrawn
MX60P1700 Withdrawn
MX60T350+260 Withdrawn
MX60T225+175 Withdrawn
MX60TP500+170 Withdrawn
MX60US0800 Withdrawn
MX60T425+255 Withdrawn
MX60T425+095 Withdrawn
MX60TP575+195 Withdrawn
MX60USP0900 Withdrawn
MX60T425+185 Withdrawn
MX60TP350+135 Withdrawn
MX60A1600 Withdrawn
MX60T200+160 Withdrawn
MX60USP1950 Withdrawn
MX60T350+105 Withdrawn
MX60T350+075 Withdrawn
MX60TP275+090 Withdrawn
MX60T350+225 Withdrawn
MX60T200+215 Withdrawn
MX60A3400 Withdrawn
MX60T425+070 Withdrawn
MX60TP275+240 Withdrawn
MX60TP125+255 Withdrawn
MX60TP200+210 Withdrawn
MX60TP200+060 Withdrawn
MX60TP275+265 Withdrawn
MX60T425+215 Withdrawn
MX60TP575+170 Withdrawn
MX60T275+165 Withdrawn
MX60TP425+125 Withdrawn
MX60TP275+135 Withdrawn
MX60T300+065 Withdrawn
MX60TP350+110 Withdrawn
MX60T500+135 Withdrawn
MX60TP500+290 Withdrawn
MX60T125+240 Withdrawn
MX60A1250 Withdrawn
MX60US1750 Withdrawn
MX60T500+255 Withdrawn
MX60T200+145 Withdrawn
MX60TP575+165 Withdrawn
MX60TP425+070 Withdrawn
MX60T500+280 Withdrawn
MX60T300+285 Withdrawn
MX60P1800 Withdrawn
MX60T150+185 Withdrawn
MX60T150+140 Withdrawn
MX60T125+165 Withdrawn
MX60TP200+165 Withdrawn
MX60T500+085 Withdrawn
MX60TP500+180 Withdrawn
MX60TP200+105 Withdrawn
MX60T300+125 Withdrawn
MX60T300+290 Withdrawn
MX60TP200+075 Withdrawn
MX60TP275+260 Withdrawn
MX60TP125+240 Withdrawn
MX60TP575+225 Withdrawn
MX60TP500+205 Withdrawn
MX60P2800 Withdrawn
MX60TP275+105 Withdrawn
MX60US2350 Withdrawn
MX60T225+060 Withdrawn
MX60T300+260 Withdrawn
MX60A2200 Withdrawn
MX60TP500+200 Withdrawn
MX60T225+160 Withdrawn
MX60P2150 Withdrawn
MX60TP275+230 Withdrawn
MX60T225+295 Withdrawn
MX60TP125+230 Withdrawn
MX60TP125+145 Withdrawn
MX60A2100 Withdrawn
MX60T350+160 Withdrawn
MX60TP125+165 Withdrawn
MX60T200+245 Withdrawn
MX60T500+110 Withdrawn
MX60TP200+125 Withdrawn
MX60A2050 Withdrawn
MX60T425+115 Withdrawn
MX60T200+095 Withdrawn
MX60T350+185 Withdrawn
MX60T200+260 Withdrawn
MX60USP2950 Withdrawn
MX60T225+135 Withdrawn
MX60T425+220 Withdrawn
MX60TP200+265 Withdrawn
MX60TP350+175 Withdrawn
MX60T500+150 Withdrawn
MX60TP125+130 Withdrawn
MX60P2900 Withdrawn
MX60TP575+140 Withdrawn
MX60A1700 Withdrawn
MX60A1150 Withdrawn
MX60T350+270 Withdrawn
MX60T500+180 Withdrawn
MX60TP125+275 Withdrawn
MX60T425+265 Withdrawn
MX60TP500+175 Withdrawn
MX60T225+105 Withdrawn
MX60T575+240 Withdrawn
MX60T125+150 Withdrawn
MX60P1850 Withdrawn
MX60T200+290 Withdrawn
MX60T300+185 Withdrawn
MX60USP2000 Withdrawn
MX60T125+275 Withdrawn
MX60TP425+195 Withdrawn
MX60TP200+130 Withdrawn
MX60US1400 Withdrawn
MX60T150+220 Withdrawn
MX60P0300 Withdrawn
MX60A1100 Withdrawn
MX60T200+295 Withdrawn
MX60T225+115 Withdrawn
MX60T125+125 Withdrawn
MX60T500+265 Withdrawn
MX60A0100 Withdrawn
MX60T575+060 Withdrawn
MX60A2350 Withdrawn
MX60T200+255 Withdrawn
MX60TP575+205 Withdrawn
MX60T300+070 Withdrawn
MX60T150+150 Withdrawn
MX60T350+240 Withdrawn
MX60P1750 Withdrawn
MX60T200+190 Withdrawn
MX60TP500+260 Withdrawn
MX60TP275+210 Withdrawn
MX60T275+300 Withdrawn
MX60P3200 Withdrawn
MX60T200+175 Withdrawn
MX60TP200+185 Withdrawn
MX60TP500+085 Withdrawn
MX60US3200 Withdrawn
MX60A2750 Withdrawn
MX60TP125+125 Withdrawn
MX60A2300 Withdrawn
MX60TP125+140 Withdrawn
MX60T225+240 Withdrawn
MX60US1650 Withdrawn
MX60T125+180 Withdrawn
MX60T275+105 Withdrawn
MX60TP575+245 Withdrawn
MX60T275+295 Withdrawn
MX60T150+075 Withdrawn
MX60A0200 Withdrawn
MX60TP275+110 Withdrawn
MX60TP425+210 Withdrawn
MX60T125+175 Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA 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
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
Suncoast Eyekon Medical, Inc. 795

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.

Recalls referencing this product code
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.

FDA premarket approvals naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer