Reported Dec 26, 2018 · Terminated
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual…
Bausch & Lomb Surgical, Inc.
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: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
- Lot codes and dates
- Model MX60E and
- specific lots of the following SKU's
MXUE0000MXUE0100MXUE0200MXUE0300MXUE0400MXUE0500MXUE0600MXUE0700MXUE0800MXUE0900MXUE1000MXUE1050MXUE1100MXUE1150MXUE1200MXUE1250MXUE1300MXUE1350MXUE1400MXUE1450MXUE1500MXUE1550MXUE1600MXUE1650MXUE1700MXUE1750MXUE1800MXUE1850MXUE1900MXUE1950MXUE2000MXUE2050MXUE2100MXUE2150MXUE2200MXUE2250MXUE2300MXUE2350MXUE2400MXUE2450MXUE2500MXUE2550MXUE2600MXUE2650MXUE2700MXUE2750MXUE2800MXUE2850MXUE2900MXUE2950MXUE3000MXUE3100MXUE3200MXUE3300and MXUE3400
- Amount recalled
- 70,440 units
Where it was sold
Why it was recalled
Cosmetic imperfections on the surface of some lenses.
This product could cause temporary or reversible health problems — stop using it.
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