Alcon Recalls Constellation Pneumatic Handpieces Due to Tip Dislodgement Risk
Alcon is removing 8,455 Constellation Pneumatic Handpieces from the market because forceps or scissors tips may dislodge if not attached according to instructions.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential mechanical failure during surgery.
Plain-English summary
Alcon Grieshaber AG is conducting a Medical Device Removal for the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01. The recall affects 8,455 units distributed worldwide, including the United States and numerous international markets.
The action is being taken because the forceps or scissors tips, which are sold separately, may dislodge from the handpiece if they are not attached by the user according to the Directions for Use. The device is indicated for both anterior and posterior segment ophthalmic surgery.
Healthcare providers and users should stop using the affected handpieces and contact Alcon for further instructions on the removal process.
The recalled product
- Product
- The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
- Manufacturer
- Alcon Grieshaber AG
- Affected units
- 8,455
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 (3)
- All Lots of the Constellation Vision System Pneumatic Handpiece
- DSP
- product number 725.01
Distribution
Distributed nationwide across the United States.
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