Class IOngoingZ-0939-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
- General Surgery Tray
- Packaging
Alcon Research LLCTXDec 31, 2025
Alcon Research LLC recalls
The FDA has posted 13 enforcement recalls from Alcon Research LLC since 2025, including 1 Class I (most serious) recall. Most recent report: Dec 31, 2025.
Class I: 1Class II: 12
Latest recalls
View all 13 in the recall browser →Class IIOngoingZ-0581-2026
Alcon Research LLC recalls CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K
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- Photocoagulator And Accessories
- Component change control
Alcon Research LLCTXDec 3, 2025
Class IIOngoingZ-0305-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
- Phacofragmentation Unit
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0307-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
- Endoilluminator
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0308-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
- Ophthalmic Trocar Cannula
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0326-2026
Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses
Potential for a weak seal in some units resulting in compromise in sterility.
- Daily Wear Soft Contact Lenses
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0306-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
- Ac-Powered Vitreous Aspiration And Cutting Instrument
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0304-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
- Instrument Cutter Vitrectomy
- Process control
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-2108-2025
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
- Instrument Cutter Vitrectomy
- Under Investigation by firm
Alcon Research LLCTXJul 16, 2025
Class IIOngoingZ-2109-2025
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
- Phacofragmentation Unit
- Under Investigation by firm
Alcon Research LLCTXJul 16, 2025
Class IIOngoingZ-2110-2025
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
- General Surgery Tray
- Under Investigation by firm
Alcon Research LLCTXJul 16, 2025
Class IIOngoingZ-1293-2025
Alcon Research LLC recalls Alcon Custom Pak with Non-Latex Symbol
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product.…
- General Surgery Tray
- Software design
Alcon Research LLCTXMar 12, 2025
Firm name as filed with the FDA: “Alcon Research LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.