Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage
Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device used in eye surgery that may leak beyond design specifications, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks. These medical devices are used to provide access into the posterior segment of the eye for surgical instruments during 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
The recall was initiated because the products have the potential to leak beyond their design specifications. The affected units were distributed in the United States and numerous international locations, including Argentina, Australia, Canada, China, Germany, Japan, and the United Kingdom.
Consumers and healthcare providers should stop using the affected products and contact Alcon Research, Ltd. for further instructions. The recall covers specific lot numbers listed in the official FDA documentation.
The recalled product
- Product
- 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 225,000
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Alcon Research, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Alcon Research, Ltd.
See all →- SevereAlcon Constellation Procedure Pak recalled due to plastic debris risk
FDA (Devices) · 2023-08-23
- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereAlcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- ModerateAlcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion
FDA (Devices) · 2018-03-07
- ModerateAlcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch
FDA (Devices) · 2018-03-07
- HighAlcon 23G Ophthalmic Cannula Recall Due to Loose Fit
FDA (Devices) · 2012-10-03
- HighAlcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall
FDA (Devices) · 2020-04-29
- HighAlcon ophthalmic surgical knives recalled for sharpness and performance degradation
FDA (Devices) · 2024-08-28
- HighFDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness
FDA (Devices) · 2024-08-28