Alcon Constellation Vision System Procedure Packs Recalled for Sterility Risk
Alcon Laboratories is recalling certain Constellation Vision System Combined Procedure Paks (89,495 units) due to potential damage to the lidding that may compromise sterility. Affected products were distributed worldwide.
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 of surgical procedure packs with potential sterility compromise in the lidding. No illnesses or injuries have been reported; the hazard is theoretical based on risk of sterility barrier failure in a high-risk surgical device.
Plain-English summary
Alcon Laboratories, Inc. is recalling Constellation Vision System Combined Procedure Paks across multiple catalog numbers and lot codes. Approximately 89,495 units were distributed worldwide, including throughout the United States.
During manufacturing, certain units within specific lots sustained damage to the lidding. This damage is visibly noticeable and may compromise the sterility of the surgical procedure pack. A compromised sterile barrier in surgical instruments poses a risk during ophthalmologic procedures.
The recalled products were distributed in all U.S. states and territories and internationally to more than 60 countries.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined 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 Constellati
- Manufacturer
- Alcon Research LLC
- Hazard
- sterility-compromise
- packaging-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 (7)
- 23G
- 5.0 CPM
- 0.9STD
- 0.9
- V
- 0.9MM
- W/O PROBE
Distribution
Distributed nationwide across the United States.
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