Alcon Laboratories, Inc.
FDA adverse event reports naming Alcon Laboratories, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ALCON LABORATORIES, INC..
- Total reports
- 5,462
- Deaths
- 1
- Injuries
- 1,669
- Malfunctions
- 3,523
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Intraocular LensHQL3,381
- Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE1,049
- Lens, Guide, IntraocularKYB441
- Accessories, Soft Lens ProductsLPN169
- Unit, PhacofragmentationHQC123
- Aid, Surgical, ViscoelasticLZP42
- Fluid, IntraocularLWL24
- Knife, OphthalmicHNN21
- Excimer Laser SystemLZS20
- Vitrectomy, Instrument CutterMLZ18
Recent recalls
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue Number: 8065751145 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation Vision System w/o Laser, Catalogue Number: 8065751147 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation Tabletop, Catalogue Number: 8065751150 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation LX, Catalogue Number: 8065751551 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 2010-07-13TerminatedSoftware design
Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Monitor Alcon Laboratories, Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.