Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall
Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.
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: The recall is classified as FDA Class II, which involves a risk of harm where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Alcon Research LLC is recalling 102 packs of the Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Lot #2128524H. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
The recall was initiated because there was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of the intended 20-gauge infusion cannula. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
There was no domestic distribution of these products. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova. Consumers and healthcare providers should stop using the affected products and contact Alcon Research LLC for further instructions.
The recalled product
- Product
- Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
- Manufacturer
- Alcon Research LLC
- Affected units
- 102
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 (1)
- Lot #2128524H
Distribution
Distribution scope not specified by the agency.
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