FDAFDA · Food and drugs·Recall number Z-0961-2019
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Published March 6, 2019 · Recall initiated: July 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Research Laboratories Ltd.
- Distributor
- Worldwide Distribution - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and US Virgins Islands Australia, Austria, Bahamas, Belarus, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Germany, Guatemala, India, Indonesia, Italy, Jamaica, Japan, Kenya, Lebanon, Mexico, Netherland Antilles, Norway, Peru, Philippines, Poland, Romania, Slovakia, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, and Vietnam
- Lot
- Model: LuxOr E71 and E71 Q-Vue 8065752304, 8065752323, 8065752332, and 8065752333 US Serial numbers: 22013, 1401148103X, 1401148201X, 1401148204X, 1401554606X, 1401845004X, 1401845005X, 1401974102X, 1401974104X, 1401974105X, 1401977002X, 1401977003X, 1402067603X, 1402067604X, 1402067605X, 1402149501X, 1402149503X, 1402149504X, 1402167704X, 1402249701X, 1402249702X, 1402249703X, 1402249803X, 1402314601X, 1402314701X, 1402314705X, 1402355101X, 1402677604X, 1402804905X, 1402877605X, 1402877701X, 1402877702X, 1402877801X, 1402877804X, 1402959102X, 1402959201X, 1402959202X, 1402959204X, 1403031005X, 1403133802X, 1403133804X, 1403133805X, 1403353401X, 1403353402X, 1403353403X, 1403353404X, 1403353405X, 1403571101X, 1403571102X, 1403571103X, 1403571104X, 1403571105X, 1403701202X, 1403701203X, 1403701204X, 1403701205X, 1403701206X, 19941, 20214, 20349, 20381, 20585, 20652, 20702, 20714, 20722, 20781, 20832, 20862, 20878, 20878-2, 20879, 20933, 21017, 21019, 21032, 21104, 21171, 21173, 21217, 21270, 21463, 21516, 21567, 21590, 21630, 21639, 21654, 21678, 21749, 21750, 21815, 21849, 21867, 21940, 21972, 22003, 22026, 22029, 22088, 22088-2, 22134, 22182, 22231, 2713, 30131, 30216, 30363, 30363-2, 30766, 31172, 31172-2, 3157, 31646, 31745, 31780, 31873, 31873-2, 31873-3, 32004, 32214, 32347, 32384, 32384-2, 32400, , 32420, 32420-2, 32439, 32453, 32553, 32568, 32643, 32694, 32694-2, 32698, 32743, 32748, 32755, 32771, 32785, 32785-2, 32785-3, 32875, 32886, 32886-2, 32896, 32909, 32923, 32923-2, 32994, 33028, 33039, 33176, 33176-2, 33263, 33270, 33313, 33325, 33348, 33348-2, 33355, 33358, 33392, 33392-2, 33440, 33442, 33454, 33460, 33464, 33498, 33498-2, 33522, 33535, 33592, 33598, 33606, 33606-2, 33606-3, 33606-4, 33653, 33769, 33775, 33783, 33849, 33850, 33850-2, 33892, 33904, 33926, 33966, 33999, 34030, 34030-2, 34033, 34099, 34099-2, 34173, 34203, 34204, 34280, 3431 1, 34312, 34352, 34352-2, 34371, 34458, 34458-2, 34468, 34556, 34562, 34564, 34597, 34616, 34627, 34627-2, 34627-3, 34679, 34680, 34682, 34682-2, 34686A-2, 34699, 34700, 34701, 34780, 34884, 34911, 34951, 34956, 34974, 34999, 34999-2, 35010, 35039, 35061, 35063, 35063-2, 35064, 35120, 35144, 35149, 35162, 35163, 35203, 35266, 35288, 35289, 35316, 35330, 35334, 5382, 35382-2, 35383, 35433, 35433-2, 35433-3, 35433-4, 35450, 35462, 35511, 35553, 35572, 35602, 35615, 35616, 35616-2, 35644, 35690, 35690-2, 35696, 35742, 35742-2, 35785, 35786, 35789, 35789-2, 35791, 35827, 35833, 35855, 35860, 35860-2, 35886, 35893-4, 35919, 35967, 35969, 35969-2, 35981, 35985, 35985-2, 35993, 36013, 36013-2, 36014, 36021, 36022, 36031, 36031-2, 36077, 36078, 40220 :002, 40220:004, 40220:006, 40232:00, 40476, 40514:001, 40516 :001, 40518:001, 40545 :003, 40547:003, 40548:003, 40609:003, 40612:003, 40680:001, 40681 :001, 40684:001, 40685 :001, 40687:001, 40688:001, 40769:001, 40770:001, 40773 :001, 40776:001, 40778 :001, 40781:001, 40783:001, 40797 :001, 40798 :001, 40801 :001, 40803:001, 40804:001, 40806 :001, 40807:001, 40837:003, 41147 :001, 41151 :001, 41153:001, 41190:001, 41212:001, 41256 :001, 4157 :001, 41266:001, 41270 :001, 41272 :001, 41273:001, 41481 :001, 41612:001, 41613 :001, 41842:001, 41853 :001, 41858:001, 41859 :001, 41860 :001, 41865 :001, 42109 :001, 42111 :001, 42321:001, 42334:001, 42345 :001, 42346 :001, 42497 :001, 42498 :001, 42500:001, 42507 :001, 42883 :001, 43178 :001, 43179 :001, 43241 :001, 43638 :001, 3640 :001, 43680 :001, 43685 :001, 43690 :001, 43691 :001, 3692 :001, 43693 :001, 43813 :001, 43814:001, 43816 :001, 43821 :001, 44025 :001, 44063 :001, 44083 :001, 44084 :001, 4090 :001, 44097 :001, 44299 :001, 44306 :001, 44308 :001, 44310 :001, 44313 :001, 44314 :001, 44357 :001, 44358 :001, A005, A006, A012, A014, A016 and A018 OUS Serial Numbers: 41242:001, 41275 :001, 41848 :001, 1401148001X, 1401148101X, 1401148104X, 1402643103X, 1402314404X, 1402314405X, 1403918102X, 1502158505X, 42119:001, 42994 :001, 44040:001, 43232 :001, 1401975304X, 140238
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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