FDA Medical Device Recalls (openFDA)
Haag-Streit USA Inc: 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.
- Recall number
- Z-2964-2011
- Recalling firm
- Haag-Streit USA Inc
- 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.
- Status
- Terminated
- Initiated
- 2011-06-20
- Posted
- 2011-08-09
- Terminated
- 2013-03-08
- Reason
- A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
- Root 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
- 216
- Distribution
- Nationwide (USA) Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K082891"]
- PMA numbers
- not on file
- Product code
- HJB
- Firm FEI
- 1000136533
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28