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MEDICAL DEVICE RECALLMODERATE

STAAR ICL Calculation Software

Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.

What to do

Physicians and clinical staff should immediately discontinue use of the Version 8.00 software for toric ICL planning and contact Staar Surgical for updated software instructions.

Recalled
Listed
Updated
Recall No.
Z-2509-2026
Agency
FDA
Firm
Staar Surgical AG
Recall ID
99007
Status
ONGOING

Why it was recalled

Staar Surgical is recalling Version 8.00 of the STAAR ICL Calculation Software due to a coding error that may result in an incorrect Implantation Orientation Diagram (IOD) for toric implantable collamer lenses. This software is used by physicians to calculate lens size and power, and the defect specifically affects the pictorial representation of the axis of rotation and alignment.

Is mine affected?

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

STAAR ICL Calculation SoftwareSoftware version: Version 8.00

UDI-DI
00840311346288
00840311346288, 0812, 8.00, 2026

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 →

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification