ClearanceBrief
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)
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Top companies in HQL

DateFirm and productCodeLinked 510(k)
Jul 17, 2013Staar 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
HQLNone listed
Mar 9, 2013Abbott 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
HQLNone listed
Feb 22, 2012Aaren Scientific, Incorporated
UV-Absorbing Posterior Chamber IOL Model: SP-65A2, Serial Number: 1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106,
Terminated
HQLNone listed
Feb 22, 2012Aaren 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
HQLNone listed
Feb 22, 2012Aaren 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
HQLNone listed
Feb 22, 2012Aaren 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
HQLNone listed
Nov 23, 2011Abbott 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
HQLNone listed
Nov 23, 2011Abbott 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
HQLNone listed
Jul 14, 2011Hoya Surgical Optics, Inc.
iSert Intraocular Lens (Model PC-60AD)
Terminated
HQLNone listed
Jul 14, 2011Hoya 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
HQLNone listed
Jun 29, 2011Staar 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
HQLNone listed
Jan 12, 2010Abbott Medical Optics Inc (AMO)
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Terminated
HQLNone listed
Jan 11, 2010Bausch & 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
HQLNone listed
Sep 9, 2009Bausch & Lomb Inc
Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
Terminated
HQLNone listed
Dec 14, 2006Advanced Medical Optics, Inc.
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
Terminated
HQLNone listed
Dec 14, 2006Advanced Medical Optics, Inc.
AMO PhacoFlex Il Model SI40NB Intraocular Lenses
Terminated
HQLNone listed
Aug 2, 2006Tekia Inc
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)
Terminated
HQLNone listed
Oct 28, 2005Advanced Medical Optics, Inc.
CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)
Terminated
HQLNone listed
Oct 28, 2005Advanced Medical Optics, Inc.
CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)
Terminated
HQLNone listed
Oct 28, 2005Advanced Medical Optics, Inc.
CeeOn EDGE Silicone Posterior Chamber IOLs (Modelsl 911A and 913A)
Terminated
HQLNone listed
Oct 28, 2005Advanced Medical Optics, Inc.
Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900)
Terminated
HQLNone listed
Oct 28, 2005Advanced Medical Optics, Inc.
Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)
Terminated
HQLNone listed
Jul 20, 2004Staar Surgical Co Inc
STAAR Surgical Intra Occular Lens, Collamer.
Terminated
HQLNone listed
Jul 20, 2004Bausch & Lomb Surgical, Inc.
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
Terminated
HQLNone listed
Feb 18, 2004Staar Surgical Co Inc
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
Terminated
HQLNone listed

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