Data / Medical devices / United States / Alcon Research, LLC
Alcon Research, LLC: FDA-registered device maker in Fort Worth, TX, United States, 35 510(k) clearances and 9 PMA approvals
Alcon Research, LLC is registered with the FDA (registration 1610287) in Fort Worth, TX, United States. It lists 27 device types. The FDA files 35 510(k) clearances and 9 PMA approvals under its listings, the newest dated November 16, 2023. 46 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1610287
- Address
- 6201 South Freeway, Fort Worth, TX, United States, 76134
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 15, 2002
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 16, 2023 | K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| September 15, 2022 | K222500 | AIR OPTIX COLORS | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 28, 2021 | K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 23, 2021 | K212039 | CLAREON MONARCH IV IOL Delivery System | MSS | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| April 12, 2021 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| September 22, 2020 | K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 21, 2020 | K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | MVN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| May 21, 2020 | K200400 | Systane iLux2 | ORZ | Substantially Equivalent | Tear Film Innovations, Inc. | accessdata.fda.gov |
| July 31, 2019 | K191795 | AOCup Lens Case with AODisc | LPN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| February 6, 2019 | K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 18, 2019 | K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 11, 2018 | K182902 | Precision1 | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 26, 2017 | K172645 | iLux Instrument, iLux Disposable | ORZ | Substantially Equivalent | Tear Film Innovations, Inc. | accessdata.fda.gov |
| October 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| November 30, 2016 | K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 26, 2015 | K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | LPN | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| March 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| May 10, 2011 | K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | Alcon Research, Ltd. | accessdata.fda.gov |
| January 24, 2008 | K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| September 14, 2005 | K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | Alcon Research, Ltd. | accessdata.fda.gov |
| May 27, 2005 | K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| March 28, 2005 | K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| June 27, 2003 | K031521 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | LPN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| August 8, 2002 | K021143 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | Alcon Universal, Ltd. | accessdata.fda.gov |
| September 16, 1999 | K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | LPN | Substantially Equivalent | Alcon Laboratories | accessdata.fda.gov |
| January 20, 1998 | K974281 | ALCON CONTACT LENS CASE | LRX | Substantially Equivalent | Alcon Laboratories | accessdata.fda.gov |
| November 27, 1996 | K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| February 17, 1989 | K890303 | OPTI-TEARS(R) | LPN | Substantially Equivalent | Alcon Laboratories | accessdata.fda.gov |
| April 29, 1988 | K880961 | ALCON SURGICAL PROCEDURE PACKS | LRO | Substantially Equivalent | Alcon Laboratories | accessdata.fda.gov |
| April 6, 1983 | K830822 | EYE DRAPE | HMT | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 25, 2023 | P220007 | Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta | LPM | 7 | March 11, 2026 | accessdata.fda.gov |
| January 7, 2020 | P190018 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | HQL | 49 | August 17, 2026 | accessdata.fda.gov |
| October 23, 2003 | P010059 | MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C | MRJ | 10 | November 4, 2024 | accessdata.fda.gov |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
| February 24, 2000 | P990023 | CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE | LZP | 18 | September 22, 2022 | accessdata.fda.gov |
| September 25, 1997 | P950008 | SILIKON 1000 | LWL | 21 | June 3, 2024 | accessdata.fda.gov |
| February 29, 1996 | P950018 | PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) | LWL | 25 | June 11, 2024 | accessdata.fda.gov |
| September 26, 1991 | P890047 | PROVISC(TM)VISCOELASTIC PREPARATION | LZP | 68 | October 1, 2026 | accessdata.fda.gov |
| April 30, 1986 | P840064 | VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES | LZP | 90 | October 1, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2025 | 98055 | Class I | Ongoing | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-des | Ophthalmic procedure packs may have incomplete seals affecting sterility. | accessdata.fda.gov |
| September 30, 2025 | 97739 | Class II | Ongoing | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Potential for a weak seal in some units resulting in compromise in sterility. | accessdata.fda.gov |
| September 15, 2025 | 97728 | Class II | Ongoing | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV.9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV.9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV.9 IU/ 80650 | XXX | accessdata.fda.gov |
| August 5, 2025 | 97415 | Class II | Ongoing | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 3 | Due to incomplete seals in the pouch which provide the sterile barrier. | accessdata.fda.gov |
| April 28, 2025 | 96832 | Class II | Ongoing | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: S | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised. | accessdata.fda.gov |
| February 10, 2025 | 96285 | Class II | Ongoing | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-1 | Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur. | accessdata.fda.gov |
| November 13, 2024 | 95903 | Class II | Ongoing | Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. | accessdata.fda.gov |
| October 15, 2024 | 95599 | Class III | Ongoing | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBI | Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. | accessdata.fda.gov |
| August 8, 2024 | 95249 | Class II | Ongoing | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere | Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision. | accessdata.fda.gov |
| July 15, 2024 | 94989 | Class II | Ongoing | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | accessdata.fda.gov |
| May 23, 2024 | 94848 | Class II | Ongoing | Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 | After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting | accessdata.fda.gov |
| April 22, 2024 | 94501 | Class II | Ongoing | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. | accessdata.fda.gov |
| April 17, 2020 | 85563 | Class II | Terminated | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS | Incorrect IOL diopter | accessdata.fda.gov |
| July 25, 2018 | 85198 | Class II | Terminated | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. | There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula. | accessdata.fda.gov |
| July 17, 2018 | 82024 | Class II | Terminated | Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. | Potential for the optical head to detach from the stand due to the lack of thread adhesive. | accessdata.fda.gov |
| June 30, 2017 | 77823 | Class II | Terminated | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order. | accessdata.fda.gov |
| May 25, 2017 | 77480 | Class II | Terminated | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope | Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. | accessdata.fda.gov |
| March 27, 2017 | 76855 | Class II | Terminated | Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured wit | Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised. | accessdata.fda.gov |
| September 5, 2016 | 75049 | Class II | Terminated | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal | The intraocular lens could become lodged within the cartridge | accessdata.fda.gov |
| July 28, 2016 | 74825 | Class II | Terminated | LAUREATE World Phaco System | Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) | accessdata.fda.gov |
| July 28, 2016 | 74824 | Class II | Terminated | Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens i | The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System | accessdata.fda.gov |
| May 24, 2016 | 74282 | Class II | Terminated | CENTURION Vision System | The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed. | accessdata.fda.gov |
| April 28, 2016 | 73998 | Class II | Terminated | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks | Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. | accessdata.fda.gov |
| April 14, 2016 | 73883 | Class II | Terminated | LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. | Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut. | accessdata.fda.gov |
| March 1, 2016 | 73430 | Class II | Terminated | VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract s | Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans. | accessdata.fda.gov |
| September 29, 2015 | 72377 | Class I | Terminated | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the e | Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. | accessdata.fda.gov |
| September 21, 2015 | 72363 | Class II | Terminated | Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. | The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves. | accessdata.fda.gov |
| August 11, 2015 | 73777 | Class II | Terminated | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. | The product has potential to leak beyond their design specification. | accessdata.fda.gov |
| August 11, 2015 | 71941 | Class II | Terminated | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE | Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure. | accessdata.fda.gov |
| June 2, 2015 | 71383 | Class II | Terminated | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle RE | Insufficient seal on the outside packaging, potentially affecting the sterility of the product. | accessdata.fda.gov |
| April 28, 2015 | 71156 | Class II | Terminated | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light | The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible. | accessdata.fda.gov |
| April 15, 2015 | 71630 | Class I | Terminated | ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crysta | There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery. | accessdata.fda.gov |
| November 11, 2014 | 69743 | Class II | Terminated | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surger | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers. | accessdata.fda.gov |
| October 30, 2014 | 69673 | Class II | Terminated | INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8 | Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line. | accessdata.fda.gov |
| October 6, 2014 | 73767 | Class II | Terminated | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts. | The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs. | accessdata.fda.gov |
| June 3, 2014 | 68487 | Class II | Terminated | eye-pak 7407 Tray Support Cover REF 8065740745 | The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. | accessdata.fda.gov |
| May 16, 2014 | 68335 | Class II | Terminated | Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cata | Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle | accessdata.fda.gov |
| April 29, 2009 | 51964 | Not yet classified | Terminated | Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. | accessdata.fda.gov |
| July 7, 2008 | 49113 | Not yet classified | Terminated | MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used | Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens. | accessdata.fda.gov |
| March 7, 2008 | 47401 | Not yet classified | Terminated | Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134. | Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction. | accessdata.fda.gov |
| July 11, 2007 | 38382 | Not yet classified | Terminated | Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each. | Mislabeled: boxes actually contained Tri-Fact needles | accessdata.fda.gov |
| January 18, 2007 | 37147 | Not yet classified | Terminated | 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203. | Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs. | accessdata.fda.gov |
| December 14, 2006 | 37009 | Not yet classified | Terminated | AcrySof ReSTOR Intraocular Lens | Intraocular lenses exposed to extreme temperatures while in storage. | accessdata.fda.gov |
| September 2, 2005 | 33409 | Not yet classified | Terminated | Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless p | Unknown residue noted on suface of flap irrigators incorporated into cusom paks. | accessdata.fda.gov |
| November 18, 2003 | 27748 | Not yet classified | Terminated | ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide | The firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ISPAN gas administered who may still have a bubble present in the eye. | accessdata.fda.gov |
| November 18, 2002 | 25047 | Not yet classified | Terminated | SKBM Microkeratome cutting tool | Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Eye Tray
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Strip, Schirmer
- All makers of Aid, Surgical, Viscoelastic
- All makers of Drape, Patient, Ophthalmic
Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.