Z-0304-2026Class II

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical...

Name: Z-0304-2026 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical...
Creator: Alcon Research LLC
Published: 2025-08-05
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2025-08-05 / Open, Classified / root cause: manufacturing process

FDA source

Alcon Research LLC began a recall of Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment... on 2025-08-05. FDA classified it as Class II and gives the reason as "Due to incomplete seals in the pouch which provide the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0304-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-10-24
Recalling firm: Alcon Laboratories
Product: 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 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Product code: MLZ Vitrectomy, Instrument Cutter
Reason for recall: Due to incomplete seals in the pouch which provide the sterile barrier.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/05/2025, the firm sent via FedEx Overnight an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that for the Alcon Standalone Vitrectomy Consumables, there is potential for some pouches within impacted lots to have an incomplete seal. Customers are instructed to: locate and dispose of any affected lots of Alcon Standalone Vitrectomy Consumables remaining in your inventory. To comply with this Medical Device Recall and request the replacement of any unused product, please take the following steps: 1. Review inventory to determine if there are any unused affected product within their facility. See table on page 1 for affected Standalone Vitrectomy Consumable lots shipped to your location. 2. Segregate and dispose of any unused affected product from their inventory. 3. Call Alcon Customer Service to arrange for replacement of the affected inventory of Alcon Standalone Vitrectomy Consumables. 4. Respond to Alcon indicating understanding of these instructions even if they have zero (0) units remaining in inventory by completing the online response form at https://qrco.de/Vit-Seal or by completing and returning the attached Response Form and returning to Alcon via email: [email protected] or fax: 817-302-4337. 5. Forward this notification to all departments within their organization who may be in possession of this affected product; and any other organization to which this product may have been transferred. For questions contact, Alcon Customer Service at 1-800-862-5266 or an Alcon Sales Representative.
Quantity in commerce: 577
Distribution: Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,
Product codes and lots: Catalog Number: 8065000250 UDI-DI code: 00380650002501 Lot/Batch Numbers: 17E6P1 17E77V Catalog Number: 8065753168 UDI-DI code: 00380657531684 Lot/Batch Number: 17EKTW Catalog Number: 8065753179 UDI-DI code: 00380657531790 Lot/Batch Number: 17E33N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0304-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0304-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0305-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0306-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0307-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0308-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code MLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)