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Terminated

EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

FDA Recall Z-1500-2017 · Posted None

Recalling FirmHaag-Streit USA Inc
Recall StatusTerminated
Product CodeNFJ
Date Initiated2017-01-05
Date Terminated2019-03-22
Product Quantity163 units

Reason for Recall

There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

Firm Action

On January 5, 2017 the firm sent Field Safety Notice to their customers.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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