Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens
Diopter: 29.0; Aspheric; Single Piece
1manufacturer
82catalogue numbers in this listing
1510(k) clearance
5recalls 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 | Staar Surgical Company, United States |
|---|---|
| FDA product code | HQL |
| Device type | Intraocular Lens |
| Device class | Class 3 |
| Regulation | 21 CFR 886.3600 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | P990013 |
| Record published | 2015-10-20 |
| 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 | expiry date, serial number |
| Storage | Storage environment temperature up to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | In distribution | |
| CQ2015A | In distribution | |
| CC4204A | In distribution | |
| CQ2015A | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913626 | 1991-12-18 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-06-10 | Class II | Material/Component Contamination | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. | 3,361 units total | 2013-10-17 |
| 2013-06-10 | Class II | Material/Component Contamination | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. | 3,361 units total | 2013-10-17 |
| 2011-05-20 | Not classified | Other | The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical’s Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nan | 16,750 devices distributed to the field | 2014-03-04 |
| 2004-06-17 | Not classified | Other | Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number. | Not specified. | 2005-01-04 |
| 2004-02-09 | Not classified | Other | Risk of hyperopic refractive changes. | No quantity applies. | 2005-01-04 |
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.