Panels › Ophthalmic › Product code HQL · Class 3
Intraocular Lens
Regulation 886.3600
0510(k)s in 12 months (5 all time)
1recalls in 12 months (75 all time)
1recalls that name a 510(k)
Top companies in HQL
| Company | 510(k)s | Recalls |
|---|---|---|
| AMO Puerto Rico Manufacturing, Inc. | 0 | 19 |
| Abbott Medical Optics Inc (AMO) | 0 | 14 |
| Bausch & Lomb Surgical, Inc. | 0 | 8 |
| Advanced Medical Optics, Inc. | 0 | 7 |
| Staar Surgical Co. | 1 | 5 |
| Aaren Scientific, Incorporated | 0 | 5 |
| Alcon Research LLC | 0 | 4 |
| Tekia Inc | 0 | 3 |
| Bausch & Lomb Inc | 0 | 2 |
| Hoya Surgical Optics, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2013 | Staar Surgical Co. nanoFLEX CC4204A Intraocular Lens
Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior c Terminated |
HQL | None listed |
| Mar 9, 2013 | Abbott Medical Optics Inc (AMO) AMO Sensar Intraocular Lenses (IOLs), Model AR40e,
Sensar Foldable IOL with OptiEdge
Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extr Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated UV-Absorbing Posterior Chamber IOL
Model: SP-65A2,
Serial Number:
1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated UV-Absorbing Posterior Chamber IOL
Model: RS-55B,
Serial Number:
1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 11 Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated Precision Aspheric Lens (PAL) Intraocular Lens
Model: EC-3 PAL,
Serial Number: 1169381106, 1169391106, 1169421106
The device is indicated for primary implantation in the capsular bag of the eye for t Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated Intraocular Lens (IOL).
Model: EC-3,
Serial Number: 1169371106, 1169401106, 1169471106
The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aph Terminated |
HQL | None listed |
| Nov 23, 2011 | Abbott Medical Optics Inc (AMO) Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for Terminated |
HQL | None listed |
| Nov 23, 2011 | Abbott Medical Optics Inc (AMO) Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for Terminated |
HQL | None listed |
| Jul 14, 2011 | Hoya Surgical Optics, Inc. iSert Intraocular Lens (Model PC-60AD) Terminated |
HQL | None listed |
| Jul 14, 2011 | Hoya Surgical Optics, Inc. iSymm Intraocular Lens (Model FC-60AD)
The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to t Terminated |
HQL | None listed |
| Jun 29, 2011 | Staar Surgical Co. Brand Name
STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single
Piece Foldable Intraocular Lens
Common Names
Collamer single piece IOL
Collamer plate haptic IOL
The Device is intend Terminated |
HQL | None listed |
| Jan 12, 2010 | Abbott Medical Optics Inc (AMO) AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) Terminated |
HQL | None listed |
| Jan 11, 2010 | Bausch & Lomb Inc Bausch & Lomb SoFlex SE Foldable Intraocular Lens.
UPC 4001404, Rx Only, STERILE.
Manufactured by:
Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759.
Intraocular lens indicat Terminated |
HQL | None listed |
| Sep 9, 2009 | Bausch & Lomb Inc Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL. Terminated |
HQL | None listed |
| Dec 14, 2006 | Advanced Medical Optics, Inc. AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses Terminated |
HQL | None listed |
| Dec 14, 2006 | Advanced Medical Optics, Inc. AMO PhacoFlex Il Model SI40NB Intraocular Lenses Terminated |
HQL | None listed |
| Aug 2, 2006 | Tekia Inc TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn Heparin SurfaceModifie (HSM) PMMA
One-Piece Anterior Chamber IOLs (Model: HSM65) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn Heparin Surface
Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn EDGE Silicone
Posterior Chamber IOLs
(Modelsl 911A and 913A) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001) Terminated |
HQL | None listed |
| Jul 20, 2004 | Staar Surgical Co Inc STAAR Surgical Intra Occular Lens, Collamer. Terminated |
HQL | None listed |
| Jul 20, 2004 | Bausch & Lomb Surgical, Inc. SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. Terminated |
HQL | None listed |
| Feb 18, 2004 | Staar Surgical Co Inc Collamer UV One-Piece IntraOcular Lens.
Models 4205BF and 4204BF Terminated |
HQL | None listed |
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