Events

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

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Haag-Streit USA Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    59426
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2964-2011
  • 사례 시작날짜
    2011-06-20
  • 사례 출판 날짜
    2011-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102758
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Biometer; Instrument Used to Measure Corneal Radius. - Product Code HJB
  • 원인
    A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using eyesuite software version i2.000.
  • 조치
    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.

Device

Device Recall Lenstar LS 900 EyeSuite Biometry version i2.000,
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution.
  • 제품 설명
    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
    Haag-Streit USA Inc

Manufacturer

Haag-Streit USA Inc
  • 제조사 주소
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • 제조사 모회사 (2017)
    Metall Zug Ag
  • Source
    USFDA