Alcon Constellation Vitrectomy Procedure Pak Recalled for Potential Manufacturing Defect
Alcon Laboratories is recalling specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential manufacturing damage to the lidding that could compromise sterility.
What this means for you
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: FDA Class II recall involving potential risk-of-harm (sterility compromise in surgical equipment) without reported illnesses or injuries. Per the rubric, theoretical hazards without confirmed adverse events score at most 3 (High).
Plain-English summary
Alcon Research LLC is recalling specific lots of the Constellation Vision System Vitrectomy Procedure Pak, a surgical procedure pack designed to interface with the Alcon Constellation surgical console for vitrectomy procedures.
The recall is due to potential damage to the lidding area sustained during manufacturing. While the damage is visibly noticeable, it creates a risk that the sterility of affected units may be compromised. No illnesses, injuries, or adverse events have been reported.
The recall affects 198,205 units distributed worldwide, including all U.S. states and territories as well as numerous countries across Europe, Asia, the Americas, Africa, and the Middle East. Alcon has provided a detailed list of affected product descriptions, catalog numbers, and specific lot codes.
Healthcare facilities should identify affected units by comparing their inventory against the provided lot codes and product identifiers. Units matching the recall criteria should be removed from use and coordinated with Alcon for return or replacement.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
- Manufacturer
- Alcon Research LLC
- Hazard
- sterility-compromise
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 23G
- 23GA
- 25+
- 27+
- V
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03