Haag-Streit EyeSuite Software Recalled for Potential Patient Data Misattribution
Haag-Streit USA Inc is recalling EyeSuite i.8.2.1.0 software due to a risk that patient data may be stored under the wrong patient on the DICOM Server.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves a data integrity error (misattribution of patient data) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving potential adverse consequences without reported immediate physical harm.
Plain-English summary
Haag-Streit USA Inc is recalling 163 units of EyeSuite i.8.2.1.0 Software for ophthalmic use, including the selection of Intra Ocular Lenses (IOLs). The software was distributed nationwide in the United States.
The recall is being conducted because there is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. This issue could result in incorrect patient records being associated with specific medical data.
Healthcare facilities and users of the affected software should contact Haag-Streit USA Inc for further instructions on how to address the data integrity issue. The recall covers specific serial numbers for various models including the EyeSuite DICOM Option, DICOM License, and associated hardware units.
The recalled product
- Product
- EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Manufacturer
- Haag-Streit USA Inc
- Affected units
- 163
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 # 7220374 EyeSuite DICOM Option
- 5036
- 1136
- 3146
- 3147
- 3148
- 3150
- 560
- 3131
- 2412 & 3011. License Only S/N: 03011
- 3210
- BP5P922
- 5617
- 724
- 1406
- 3204
- 2306
- 2314
- 2514
- 3087
Distribution
Distributed nationwide across the United States.
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