Skip to main content
Recall Canary
TECNIS Eyhance IOL with Simplicity Delivery System
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

TECNIS Eyhance IOL with Simplicity Delivery System

AMO is recalling TECNIS Eyhance IOLs with Simplicity Delivery System (model DIB00) because the lens may fail to unfold properly.

What to do

Surgeons and healthcare facilities should immediately stop using the affected model DIB00 delivery systems and return them to the manufacturer.

Recalled
Listed
Updated
Recall No.
Z-1634-2026
Agency
FDA
Firm
AMO Puerto Rico Manufacturing, Inc.
Recall ID
98402
Status
ONGOING

Why it was recalled

AMO Puerto Rico Manufacturing is recalling specific intraocular lenses because a haptic may stick to the optic, preventing the lens from unfolding as expected during implantation. This issue affects the TECNIS Eyhance IOL with the TECNIS Simplicity Delivery System, model DIB00.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

TECNIS Eyhance IOL with TECNIS Simplicity" Delivery SystemModel/Catalog number: DIB00

UDI-DI
05050474731776, 2409342403, 2410072403, 2409612403, 2409692403, 2409752403, 2891682403, 2891132403, 2892032403, 2531882403, 2531902403, 2531212403, 2530842403, 2531242403, 2531892403, 2531622403
–

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification