Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Recalled by Haag-Streit USA Inc Due to There is a possibility for data to be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Haag-Streit USA Inc directly.
Affected Products
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Quantity: 163 units
Why Was This Recalled?
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Haag-Streit USA Inc
Haag-Streit USA Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report