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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon or Endure Ophthalmic Microscope (LuxOR E71 and LuxOR E71 QVue)

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  Class 2 Device Recall Alcon or Endure Ophthalmic Microscope (LuxOR E71 and LuxOR E71 QVue) see related information
Date Initiated by Firm July 17, 2018
Date Posted February 27, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0961-2019
Recall Event ID 82024
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
Product Alcon or Endure Ophthalmic Microscope

Product Usage:
Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
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.     
Recalling Firm/
Manufacturer		 Alcon Research Laboratories Ltd.
Aspex Facility
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
800-832-7827
Manufacturer Reason
for Recall		 Potential for the optical head to detach from the stand due to the lack of thread adhesive.
FDA Determined
Cause 2		 Device Design
Action On July 17, 2018 the firm sent letters to their consignees with the following instructions: To assist us in this Voluntary Medical Device Correction, please take the following steps: 1. Inspect your microscope prior to continued use per the instruction above. 2. If either the Functional or Visual tests have failed, stop use of the device immediately and notify Alcon at 1-800-832-7827. 3. Forward this information immediately to all departments within your organization who may be using the Alcon or Endure LuxOR E71 Ophthalmic Microscope and Alcon or Endure LuxOR E71 Q-Vue Ophthalmic Microscope. 4. If applicable, provide a copy of this notification to any other organization I location to which the Alcon or Endure LuxOR E71 Ophthalmic Microscope and Alcon or Endure LuxOR E71 Q-Vue Ophthalmic Microscope has been sold or moved. 5. Return the attached Response Form via fax or email to Alcon.
Quantity in Commerce 544 (399 units to USA)
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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