Class 2 Device Recall Lenstar LS 900

• Date Initiated by Firm: May 19, 2010
• Date Posted: June 24, 2010
• Recall Status: Terminated 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: 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