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Terminated

Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

FDA Recall Z-0961-2019 · Posted 2019-02-27

Recalling FirmAlcon Research Laboratories Ltd.
Recall StatusTerminated
Product CodeHRM
Date Initiated2018-07-17
Date Terminated2021-04-28
Product Quantity544 (399 units to USA)

Reason for Recall

Potential for the optical head to detach from the stand due to the lack of thread adhesive.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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