Device Recall Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL

  • 모델명 / 제조번호(시리얼번호)
    Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of OK, KS, FL, and AL.
  • 제품 설명
    Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • 제조사 모회사 (2017)
  • Source
    USFDA