Class 2 Device Recall Lenstar LS 900 EyeSuite Biometry version i2.000,

• Date Initiated by Firm: June 20, 2011
• Date Posted: August 09, 2011
• Recall Status: Terminated on March 08, 2013
• Recall Number: Z-2964-2011
• Recall Event ID: 59426
• 510(K)Number: K082891
• Product Classification: Biometer; Instrument Used to Measure Corneal Radius. - Product Code HJB
• Product: 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.
• Code Information: Part Number 7220162. Serial Numbers: 21, 127, 223, 224, 284, 285, 316, 318, 319, 320, 322, 323, 324, 325, 326, 327, 328, 330, 331, 332, 333, 364, 365, 366, 368, 369, 371, 372, 376, 378, 379, 381, 384, 385, 386, 405, 407, 408, 409, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 423, 424, 443, 446, 447, 448, 449, 450, 452, 453, 454, 455, 456, 457, 458, 459, 460, 463, 469, 470, 481, 482, 483, 484, 485, 486, 487, 489, 490, 491, 492, 493, 494, 495, 496, 497, 499, 500, 527, 528, 529, 531, 532, 533, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 558, 559, 560, 561, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 576, 578, 579; ; 581, 582, 583, 584, 585, 587, 588, 589, 590, 618, 619, 620, 621, 622, 624, 625, 626, 628, 630, 631, 632, 633, 634, 635, 636, 638, 639, 640, 641, 643, 644, 645, 647, 648, 649, 650, 651, 652, 653, 654, 656, 657, 658, 659, 660, 661, 662, 663, 665, 667, 668, 669, 670, 671, 672, 674, 675, 676, 677, 721, 723, 724, 725, 726, 727, 728, 729, 735, 824, 825, 922, 946, 966, 967, 968, 970, 1018, 1019, 1021, 1022, 1024, 1025, 1114, 1143 & 1195.
• Recalling Firm/ Manufacturer: Haag-Streit USA Inc; 3535 Kings Mills Rd; Mason OH 45040
• For Additional Information Contact: Russell F. Wolfe; 513-398-3937 Ext. 1167
• Manufacturer 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.
• FDA Determined Cause: Software change control
• 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.
• Quantity in Commerce: 216
• Distribution: Nationwide (USA) Distribution.
• 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 = HJB and Original Applicant = HAAG-STREIT AG