Z-0305-2026Class II
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical...
Alcon Laboratories / initiated 2025-08-05 / Open, Classified / root cause: manufacturing process
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 . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0305-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- 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' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID 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
- HQC Unit, Phacofragmentation
- 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
- 25,778
- 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: 8065750918 UDI-DI code:00380657509188 Lot/Batch Number: 1790L4 Catalog Number: 8065750957 UDI-DI code: 00380657509577 Lot/Batch Numbers: 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 Catalog Number: 8065750972 UDI-DI code: 00380657509720 Lot/Batch Numbers: 17C8T2 17C8T4 17E0TX Catalog Number: 8065751014 UDI-DI code: 00380657510146 Lot/Batch Numbers: 1789PV 1789PW 1788DD 1788DE 17C2MY 17C2NE 17DL3P 17DL3U 17DL3W 17DL3X 17E0WU 17E0X0 17F4D6 Catalog Number: 8065751441 UDI-DI code: 00380657514410 Lot/Batch Numbers: 17C6U5 17C359 17C35A Catalog Number: 8065751577 UDI-DI code: 00380657515776 Lot/Batch Numbers: 1789P4 1789P5 1789P6 179MCD 17C2RV 17C2RY 17C2T3 17DPN7 17DPN8
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0304-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0305-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0306-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0307-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0308-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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