143 results
·
84ms
·
Sources: EU EUDAMED, US FDA
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
FDA Enforcement
Class II
·Terminated·Abbott Medical Optics, Inc.·July 17, 2013
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code LZS·September 16, 2013
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
FDA Recall
Terminated
·Abbott Medical Optics, Inc.·Product code HQC·May 23, 2013
CATALYS LOI
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC. (AMO)·Product code OOE·November 28, 2016
TECNIS 1-PIECE IOL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC (AMO)·Product code HQL·May 29, 2014
TECNIS 1-PIECE IOL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code HQL·May 29, 2014
TECNIS 1-PIECE IOL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC. (AMO)·Product code HQL·May 29, 2014
TECNIS 1 PIECE IOL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC. (AMO)·Product code HQL·May 29, 2014
CATALYS LOI
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC. (AMO)·Product code OOE·December 12, 2016
CATALYS LOI
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code OOE·December 12, 2016
CATALYS LOI
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS, INC. (AMO)·Product code OOE·January 24, 2017
TECNIS ZCBOO 22.0 DIOPTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code MFK·August 4, 2016
INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code HQL·April 4, 2017
LIQUID OPTICS INTERFACE (CATALYS)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC.(AMO)·Product code OOE·August 23, 2017
LIQUID OPTICS INTERFACE (CATALYS)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code OOE·August 23, 2017
LIQUID OPTICS INTERFACE (CATALYS)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS INC.(AMO)·Product code OOE·September 13, 2017
EXCIMER LASER
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS INC. (AMO)·Product code LZS·February 2, 2018