Reported Jun 12, 2013 · Terminated
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic…
Alcon Grieshaber AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Grieshaber AG · Winkelriedstrasse 52 · Schaffhausen, N/A · N/A
Is this the product you have?
- The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
- Lot codes and dates
- All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
- Amount recalled
- 8,455 units
Where it was sold
- Nationwide
Why it was recalled
Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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