FDA Recall
Terminated
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Recall: Z-1500-2017
·
Initiated January 5, 2017
Recall
- Recall Number
- Z-1500-2017
- Event Number
- 76405
- Firm
- Haag-Streit USA Inc
- FEI Number
- 1000136533
- Product Code
- NFJ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 5, 2017
- Terminated
- March 22, 2019
- Address
- 3535 Kings Mills Rd, Mason, OH, 45040-2303
Description
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Reason
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Action
On January 5, 2017 the firm sent Field Safety Notice to their customers.
Distribution
US Nationwide distribution.
Quantity
163 units