Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AlconLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Alcon Research with 106 device recalls, 18 510(k) clearances and 4 drug recalls. The most recent is a device recall dated Mar 15, 2024: Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodisse….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procClass II · Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Device recalls |
| Feb 21, 2024 | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-Class II · Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syrin | Device recalls |
| Sep 7, 2023 | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTRClass II · Custom surgical procedure packs contain latex gloves but are labeled as "latex free". | Device recalls |
| Aug 18, 2023 | Constellation Vision System, REF: 8065751150Class II · Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage | Device recalls |
| Mar 10, 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 Class II · Sterility; Steril surgical procedure packs contain incomplete seals. | Device recalls |
| Oct 31, 2022 | Alcon Custom Pak Surgical Procedure PackClass II · Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the pr | Device recalls |
| Jun 9, 2022 | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOClass II · Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. | Device recalls |
| Feb 2, 2021 | Alcon Custom Ophthalmic Surgical Procedure PacksClass II · Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages. | Device recalls |
| Nov 1, 2019 | LEGION SystemK191650 · HQC | 510(k) clearances |
| Apr 14, 2017 | CENTURION Vision System (Active SentryTM)K161794 · HQC | 510(k) clearances |
| Mar 22, 2017 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+K170520 · MLZ | 510(k) clearances |
| Feb 9, 2016 | TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use VClass II · Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the | Drug recalls |
| Sep 30, 2014 | WAVELIGHT FS200 LASER SYSTEMK141476 · OOE | 510(k) clearances |
| Aug 22, 2014 | CONSTELLATION VISION SYSTEMK141065 · HQE | 510(k) clearances |
| Jun 21, 2012 | WAVELIGHT FS200 PATIENT INTERFACE 1505K121031 · GEX | 510(k) clearances |
| Mar 27, 2012 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)K112977 · MSS | 510(k) clearances |
| Oct 17, 2011 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAK110951 · HQB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
