The Recall Desk
ModerateFDA (Devices)·Z-0628-2019·Announced 2018-12-26

Bausch & Lomb Recalls enVista Intraocular Lenses Due to Surface Imperfections

Bausch & Lomb is recalling 70,440 enVista intraocular lenses due to cosmetic surface imperfections. The lenses are distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is described as 'cosmetic imperfections' with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling 70,440 units of the enVista One Piece Hydrophobic Acrylic Intraocular lens. The recall is due to cosmetic imperfections found on the surface of some lenses. The affected product is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed.

The recall includes Model MX60E and specific lots of various SKUs. The product was distributed nationwide to states including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

The FDA has classified this as a Class II recall. Consumers and healthcare providers should contact Bausch & Lomb Surgical, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
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.
Manufacturer
Bausch & Lomb Surgical, Inc.
Category
Medical Device — Intraocular Lens
Hazard
Affected units
70,440

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 (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

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