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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Alcon Research LLC
- Reason for Recall:
- Due to incomplete seals in the pouch which provide the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0305-2026
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Potential for a weak seal in some units resulting in compromise in sterility.
Due to incomplete seals in the pouch which provide the sterile barrier.