Recall Z-0961-2019 ยท HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Alcon Research Laboratories Ltd.
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
| Date | Feb 27, 2019 (initiated Jul 17, 2018) |
| Status | Terminated |
| Reason | Potential for the optical head to detach from the stand due to the lack of thread adhesive. |
| 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. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.