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U.S. Department of Health and Human Services

Class 2 Device Recall Lenstar LS 900

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  Class 2 Device Recall Lenstar LS 900 see related information
Date Initiated by Firm May 19, 2010
Date Posted June 24, 2010
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1897-2010
Recall Event ID 55857
510(K)Number K082891  
Product Classification Device, measuring, lens radius, ophthalmic - Product Code HLF
Product Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland.

Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.
Code Information SERIAL Numbers: 223, 224, 225, 284, 285, 316, 317, 319, 320, 322, 323, 324, 325, 327, 330, 331, 332, 333, 364, 365, 366, 368, 369, 377, 378, 379, 381, 384, 385, 386, 405, 407, 408, 409, 411, 412, 413, 415, 416, 452, 454, 460, 461, 490 and 494.
Recalling Firm/
Manufacturer		 Haag-Streit USA Inc
3535 Kings Mills Rd
Mason OH 45040
For Additional Information Contact
513-398-3937 Ext. 1167
Manufacturer Reason
for Recall		 During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in
FDA Determined
Cause 2		 PMA
Action HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated. For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255.
Quantity in Commerce 45 units
Distribution Nationwide Distribution -- Including AL, AZ, CA, FL, ID, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, VA, VT, WA and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HLF and Original Applicant = HAAG-STREIT AG
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