FDA-Device2017-03-29Class II
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Haag-Streit USA Inc
Hazard
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Sold states
US Nationwide distribution.
Affected count
163 units
Manufactured in
3535 Kings Mills Rd, Mason, OH, United States
Products
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2017Don't want to check this manually?
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