Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Alcon Surgical Console Accessory Devices Recalled for Sterile Barrier Defect

Agency Publication Date: October 24, 2025
Share:
Sign in to monitor this recall

Summary

Alcon Laboratories, Inc. is recalling approximately 28,323 accessory devices used with Unity and Constellation surgical consoles, including vitrectomy probes, illumination tools, and infusion cannulas. The recall was initiated because the sterile pouches used to package these devices may have incomplete seals, which could compromise the sterile barrier. These products are standalone accessories used specifically in surgical procedures involving the eye.

Risk

An incomplete seal on the packaging pouch can compromise the sterile barrier, allowing the device to become contaminated before use. This poses a potential risk of infection to patients during surgery, which could lead to serious medical complications.

What You Should Do

  1. This recall affects multiple standalone accessory devices for Unity and Constellation surgical consoles, including Hypervit probes, endoilluminators, gas fill paks, chandeliers, entry systems, and infusion cannulas.
  2. Identify if you have affected products by checking the catalog number, UDI-DI code, and lot numbers on the device packaging. Affected catalog numbers include 8065000250, 8065753168, 8065753179, 8065750918, 8065750957, 8065750972, 8065751014, 8065751441, 8065751577, 8065000393, 8065000252, 8065000253, 8065000356, 8065000358, 8065000359, 8065000467, and 8065000468. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any affected stock to prevent accidental use.
  4. Contact Alcon Research LLC or your product distributor to arrange for the return, replacement, or correction of the recalled units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled devices. Contact Alcon Research LLC or your distributor to arrange for the return, replacement, or correction of the products.

Affected Products

Product: Unity and Constellation Surgical Console Accessory Devices - Vitrectomy Probes
Variants: UNITY 27+DS HYPERVIT 30K VIT PROBE, UNITY 25+ 7.5K ANTERIOR VIT PROBE, UNITY 25+ HYPERVIT 30K VIT PROBE
Model / REF:
8065000250
8065753168
8065753179
Lot Numbers:
17E6P1
17E77V
17EKTW
17E33N
UDI:
00380650002501
00380657531684
00380657531790

Recall #: Z-0304-2026; Quantity: 577

Product: Unity and Constellation Surgical Console Accessory Devices - Lines, Packs, and Illuminators
Variants: PAK,I/A LINE,NGVS, ASSY,SHIP,CONSTELLATION VFC, ENDOILLUMATOR,RFID,23G, CONST AUTO GAS FILL PAK, ENDOILLUMINATOR,RFID,25G, CHANDELIER,25GA,W/RFID
Model / REF:
8065750918
8065750957
8065750972
8065751014
8065751441
8065751577
Lot Numbers (55):
1790L4
1788D3
1788DC
1788D1
1790T0
179LNP
179LNT
179LNV
179LP2
179LPA
17A0P8
17A0PC
17A0PH
17C125
17CJEW
17CXT3
17D0RY
17DL3Y
17DL40
17DL41
17DL42
17DL46
17DPRT
17DPRU
17ERNK
17F2NR
17F55K
17C8T2
17C8T4
17E0TX
1789PV
1789PW
1788DD
1788DE
17C2MY
17C2NE
17DL3P
17DL3U
17DL3W
17DL3X
17E0WU
17E0X0
17F4D6
17C6U5
17C359
17C35A
1789P4
1789P5
1789P6
179MCD
UDI:
00380657509188
00380657509577
00380657509720
00380657510146
00380657514410
00380657515776

Recall #: Z-0305-2026; Quantity: 25,778

Product: Unity and Constellation Surgical Console Accessory Devices - VFC Pack
Variants: UNITY HP VISCOUS FLUID CONTROL VFC PACK
Model / REF:
8065000393
Lot Numbers:
17CDKX
UDI:
00380650003935

Recall #: Z-0306-2026; Quantity: 6

Product: Unity and Constellation Surgical Console Accessory Devices - Chandeliers and Probes
Variants: UNITY 27 GA CHANDELIER, UNITY 27+DS WIDE ANGLE LIGHT PROBE
Model / REF:
8065000252
8065000253
Lot Numbers:
17CMKR
17D417
17CDMX
UDI:
00380650002525
00380650002532

Recall #: Z-0307-2026; Quantity: 330

Product: Unity and Constellation Surgical Console Accessory Devices - Entry Systems and Cannulas
Variants: 27GA HP ENTRY SYSTEM, 4 MM, 25GA HP ENTRY SYSTEM, 6 MM, 27GA HP ENTRY SYSTEM, 6 MM, 25GA INFUSION CANNULA, 27GA INFUSION CANNULA
Model / REF:
8065000356
8065000358
8065000359
8065000467
8065000468
Lot Numbers:
17CFND
17CMKW
17DR9L
17DWCY
17CP3T
17CP3U
UDI:
00380650003560
00380650003584
00380650003591
00380650004673
00380650004680

Recall #: Z-0308-2026; Quantity: 1,632

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97415
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Alcon Research LLC; Authorized medical distributors
Manufactured In: United States
Units Affected: 5 products (577; 25,778; 6; 330; 1632)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.