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Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility Recalls

All product recalls associated with Alcon Research LLC Aspex Facility.

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Recall Summary

Total Recalls

36

Past Year

6

Class I (Serious)

1

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–36 of 36 recalls

Alcon Research LLC Aspex Facility: Product Desc: Product Name: ClearCut S Safety Sideport Kn...

Laceration Risk

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.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: Product Desc: Product Name: 20 Gauge V-Lance Knife Model/...

Laceration Risk

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.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: Product Name: Alcon Custom Pak Model/Catalog Number: Many...

12

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Laceration Risk

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.

Moderate

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1...

Laceration Risk

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.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog N...

Laceration Risk

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.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: Surgical Image Guidance Functionality, software used with...

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 in decreased uncorrected visual acuity.

FDAMay 23, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 S...

Laceration Risk

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.

FDAApr 22, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Cat...

Laceration Risk

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.

FDAApr 22, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research LLC Aspex Facility: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/C...

Laceration Risk

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.

FDAApr 22, 2024Nationwide• Alcon Research LLC Aspex Facility

Alcon Research, LLC: Various Alcon Custom Paks Surgical Procedure Pack contain...

Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.

FDAMar 15, 2024Nationwide• Alcon Research, LLC

Alcon Research, LLC: SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged in...

Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.

FDAFeb 21, 2024Nationwide• Alcon Research, LLC

Alcon Research, LLC: Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 4...

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

FDASep 7, 2023VA• Alcon Research, LLC

Alcon Research, LLC: Constellation Vision System, REF: 8065751150

Laceration Risk

Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

FDAAug 18, 2023GA, IL, PR• Alcon Research, LLC

Alcon Research, LLC: Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pa...

Sterility; Steril surgical procedure packs contain incomplete seals.

FDAMar 10, 2023AL, AR, CA +11 more• Alcon Research, LLC

Alcon Research, LLC: Alcon Custom Pak Surgical Procedure Pack

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

FDAOct 31, 2022Nationwide• Alcon Research, LLC

Alcon Research, LLC: Alcon Custom Pak Surgical Procedure Pack: 16998-11 251935...

Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

FDAJun 9, 2022AZ, CA, MO +1 more• Alcon Research, LLC