Alcon Constellation procedure packs may have damaged lidding compromising sterility
Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.
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: Risk-of-harm product: possible compromise of the sterile barrier on an ophthalmic surgical pack, with no infection reported in the source.
Plain-English summary
The Alcon Constellation Vision System Combined Procedure Pak, a surgical pack, is being recalled across the model and catalog numbers listed in the manufacturer's affected product list. The action covers 89,495 units.
According to the manufacturer, some units within specific lots were potentially damaged during the manufacturing process, with the area of damage within the same area of the lidding. The manufacturer states that while the damage in the lidding is visibly noticeable, the recall is being made due to the risk of sterility being compromised. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States. The packs are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the manufacturer's affected product list and follow the instructions issued by Alcon.
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
- Affected units
- 89,495
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
Part of a larger recall action
This product is one of 3 recalled by Alcon Research LLC 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.
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