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

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • Manufacturer Parent Company (2017)
  • Source
    USFDA