FDA
Alcon or Endure Ophthalmic Microscope
Product Usage:
Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
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.