Z-0961-2019Class II

Alcon or Endure Ophthalmic Microscope

Name: Z-0961-2019 Alcon or Endure Ophthalmic Microscope
Creator: Alcon Research Laboratories Ltd.
Published: 2018-07-17
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2018-07-17 / Terminated / root cause: design

FDA source

Alcon Research Laboratories Ltd. began a recall of Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and... on 2018-07-17. FDA classified it as Class II and gives the reason as "Potential for the optical head to detach from the stand due to the lack of thread adhesive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0961-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-17
Posted: 2019-02-27
Terminated: 2021-04-28
Recalling firm: Alcon Laboratories
Product: Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Product code: HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Reason for recall: Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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, 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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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0961-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0961-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-26

Product code HRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)