262 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code HQL·November 11, 2009
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016
Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900)
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code HQL·October 5, 2005
iSert Intraocular Lens (Model PC-60AD)
FDA Recall
Terminated
·Hoya Surgical Optics, Inc.·Product code HQL·June 17, 2011
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 the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code HQL·September 20, 2011
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
FDA Recall
Terminated
·Medicel Ag Luchton 1262 Wolfhalden Switzerland·Product code HQL·August 5, 2013
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·January 28, 2014
UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 1167231106, 1167241106, 1167251106, 1167261106, 1167271106, 1167281106, 1167291106, 1167301106, 1167311106, 1167321106, 1167331106, 1167341106, 1167351106, 1167361106, 1167371106, 1167381106, 1167391106, 1167401106, 1167411106, 1167421106, 1167431106, 1167441106, 1167451106, 1167461106, 1167471106, 1167481106, 1167491106, 1167501106, 1167511106, 1167521106, 1167531106, 1167541106, 1167551106, 1167561106, 1167571106, 1167581106, 1167591106, 1167601106, 1167611106, 1167621106, 1167631106, 1167641106, 1167651106, 1167661106, 1167671106, 1167681106, 1167691106, 1167701106, 1167711106, 1167721106, 1167731106, 1167741106, 1167751106, 1167761106, 1167771106, 1167781106, 1167791106, 1167801106, 1167811106, 1167821106, 1167831106, 1167841006, 1167851106, 1167861106, 1167871106, 1167881106, 1167891106, 1167901106, 1167911106, 1167921106, 1167931106, 1167941106, 1167951106, 1167961106, 1167971106, 1167981106, 1167991106, 1168001106, 1168011106, 1168021106, 1168031106, 1168041106, 1168051106, 1168061106, 1168071106, 1168081106, 1168091106, 1168101106, 1168111106, 1168121106, 1168131106, 1168141106, 1168151106, 1168161106, 1168171106, 1168181106, 1168191106, 1168201106, 1168211106, 1168221106, 1168231106, 1168241106, 1168251106, 1168261106, 1168271106, 1168281106, 1168291106, 1168301106, 1168311106, 1168321106, 1168331106, 1168341106, 1168351106, 1168361106, 1168371106, 1168381106, 1168391106, 1168401106, 1168411106, 1168421106, 1168431106, 1168441106, 1168451106, 1168461106. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
FDA Recall
Terminated
·Aaren Scientific, Incorporated·Product code HQL·August 2, 2011
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
FDA Recall
Open, Classified
·AMO Puerto Rico Manufacturing, Inc. Rd #·Product code HQL·February 19, 2026
Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code HQL·October 5, 2005
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
FDA Recall
Terminated
·Staar Surgical Co Inc·Product code HQL·February 9, 2004
STAAR Surgical Intra Occular Lens, Collamer.
FDA Recall
Terminated
·Staar Surgical Co Inc·Product code HQL·June 17, 2004
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
FDA Recall
Terminated
·Bausch & Lomb Surgical, Inc.·Product code HQL·October 16, 2013
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
FDA Recall
Terminated
·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014