Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.
FDA Recall Z-2964-2011 · Posted 2011-08-09
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Recalling FirmHaag-Streit USA Inc
Recall StatusTerminated
Product CodeHJB
Date Initiated2011-06-20
Date Terminated2013-03-08
Product Quantity216
Reason for Recall
A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
Firm Action
Haag-Streit USA, Inc. sent an "Urgent Field Safety Notices" dated June 20, 2011 to all affected customers.
The letter included a description of the affected product and problem. The firm instructed their customers to make sure all new and current templates are saved and upgrade to EyeSuite version i4.000. Customers are asked to complete and return the Software Update Verification Form.
For additional information contact the Haag-Streit at (513) 398-3937.
Root Cause
Software change control
Distribution Pattern
Nationwide (USA) Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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