Class II — Alcon Research Laboratories Ltd.
| Recalling firm | Alcon Laboratories, Inc. |
|---|---|
| Registered facility | View this company's 25 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for the optical head to detach from the stand due to the lack of thread adhesive. |
| Product | Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. |
| Quantity | 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 Salvad… |
| Initiated | 2018-07-17 |
| Classified | 2019-02-26 |
| Terminated | 2021-04-28 |
| Recall number | Z-0961-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Alcon Research Laboratories Ltd. (Z-0961-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82024/
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