Recall Z-0961-2019— Alcon Research Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research Laboratories Ltd., initiated 2018-07-17, terminated 2021-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.. Reason: Potential for the optical head to detach from the stand due to the lack of thread adhesive..
- Recalling firm
- Alcon Research Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-17
- Terminated
- 2021-04-28
- Firm location
- Fort Worth, TX, United States
Product description
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Reason for recall
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Data sourced from openFDA. This site is unofficial and independent of the FDA.