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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0600, MXUE0700, MXUE0800, MXUE0900, MXUE1000, MXUE1050, MXUE1100, MXUE1150, MXUE1200, MXUE1250, MXUE1300, MXUE1350, MXUE1400, MXUE1450, MXUE1500, MXUE1550, MXUE1600, MXUE1650, MXUE1700, MXUE1750, MXUE1800, MXUE1850, MXUE1900, MXUE1950, MXUE2000, MXUE2050, MXUE2100, MXUE2150, MXUE2200, MXUE2250, MXUE2300, MXUE2350, MXUE2400, MXUE2450, MXUE2500, MXUE2550, MXUE2600, MXUE2650, MXUE2700, MXUE2750, MXUE2800, MXUE2850, MXUE2900, MXUE2950, MXUE3000, MXUE3100, MXUE3200, MXUE3300, and MXUE3400.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Bausch & Lomb Surgical, Inc.
- Reason for Recall:
- Cosmetic imperfections on the surface of some lenses.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0600, MXUE0700, MXUE0800, MXUE0900, MXUE1000, MXUE1050, MXUE1100, MXUE1150, MXUE1200, MXUE1250, MXUE1300, MXUE1350, MXUE1400, MXUE1450, MXUE1500, MXUE1550, MXUE1600, MXUE1650, MXUE1700, MXUE1750, MXUE1800, MXUE1850, MXUE1900, MXUE1950, MXUE2000, MXUE2050, MXUE2100, MXUE2150, MXUE2200, MXUE2250, MXUE2300, MXUE2350, MXUE2400, MXUE2450, MXUE2500, MXUE2550, MXUE2600, MXUE2650, MXUE2700, MXUE2750, MXUE2800, MXUE2850, MXUE2900, MXUE2950, MXUE3000, MXUE3100, MXUE3200, MXUE3300, and MXUE3400.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0628-2019
Related Recalls
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Bausch & Lomb Surgical
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.