Device product
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Z-0961-2019
Product summary
- Event
- Event 82024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 544 (399 units to USA)
- Official record key
device-enforcement:Z-0961-2019
Official wording
Reason: Potential for the optical head to detach from the stand due to the lack of thread adhesive.
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.
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
Derived failure modes
-
Unknown
Potential for the optical head to detach from the stand due to the lack of thread adhesive.