Home / Recalls / Alcon Research Laboratories Ltd. / Z-0961-2019

Z-0961-2019 Class II Terminated

Recalled by Alcon Research Laboratories Ltd. — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
March 6, 2019
Initiation Date
July 17, 2018
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
544 (399 units to USA)

Product Description

Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

Reason for Recall

Potential for the optical head to detach from the stand due to the lack of thread adhesive.

Distribution Pattern

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

Code Information

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, 1402388004X, 43238:001, 43240:001, 41841 :001, 41258 :001, 1401554610X, 1401954603X, 1402067602X, 1402677602X, 41891:001, 43000 :001, 43246:001, 43487 :001, 43546 :001, 43547 :001, 43566 :001, 1401148203X, 1402250002X, 1403600301X, 1403600305X, 1501088505X, 1501247401X, 1501247403X, 1401148105X, 43947 :001, 44027 :001, 41225 :001, 42348 :001, 42998 :001, 43002 :001, 43167 :001, 1401148202X, 41140 :001, 42201:001, 43045 :001, 43400 :001, 42793 :001, 42796 :001, 1501355802X, 43548 :001, 1401554603X, 1401579101X, 1401579103X, 1401831601X, 1401991002X, 1403211805X, 1502004802X, 43557:001, 43633:001, 43645:001, 44058:001, 44060:001, 44093:001, 44095:001, 44096:001, 1402643102X, 42115:001, 1401975302X, 1402677603X, 1402677605X, 1403133905X, 1501088502X, 1501088506X, 1501088507X, 1501088508X, 1501247402X, 40610 :003, 41070:001, 41073:001, 41143:001, 41226:001, 41240 :001, 41627 :001, 41628:001, 43234:001, 43236 :001, 43237 :001, 43239:001, 44054:001, 1402388002X, 101200157, 1403331702X, 1403331805X, 43256 :001, 43549 :001, 41619 :001, 42797 :001, 43172 :001, 43301 :001, 41631:001, 41632 :001, 1402677601X, 41616 :001, 1402249804X, 1402314402X, 40611 :003, 40853:002, 41261:001, 41854:001, 42114:001, 42347 :001, 42588:001, 42608 :001, 43486 :001, 43644 :001, 1401554608X, 41688:001, 43173 :001, 43177-001, 43229:001, 43683:001, 42105 :001, 42107:001, 42108 :001, 43789:001, 43790 :001, 43791 :001, 44048 :001, 44049 :001, 44050 :001, 42503 :001, 1401554509X, 40805 :001, 41482 :001, 41611 :001, 41846 :001, and 42110 :001.