RecallRadar

FDA Device recall Z-0961-2019

Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cat…

On 2019-03-06 the FDA classified a Class II recall of Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cat… by Alcon Research Laboratories, citing potential for the optical head to detach from the stand due to the lack of thread adhesive.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0961-2019
ClassificationClass II
Statusterminated
Initiated2018-07-17
Published2019-03-06
Last updated2026-09-13 11:55 UTC
CompanyAlcon Research Laboratories
DistributionUS

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.

Identifiers

code_info
Model: LuxOr E71 and E71 Q-Vue 8065752304, 8065752323, 8065752332, and 8065752333 US Serial numbers: 22013, 14011481…Model: LuxOr E71 and E71 Q-Vue 8065752304, 8065752323, 8065752332, and 8065752333 US Serial numbers: 22013, 1401148103X, 1401148201X, 1401148204X, 1401554606X, 1401845004X, 1401845005X, 1401974102X, 1401974104X, 1401974105X, 1401977002X, 1401977003X, 1402067603X, 1402067604X, 1402067605X, 1402149501X, 1402149503X, 1402149504X, 1402167704X, 1402249701X, 1402249702X, 1402249703X, 1402249803X, 1402314601X, 1402314701X, 1402314705X, 1402355101X, 1402677604X, 1402804905X, 1402877605X, 1402877701X, 1402877702X, 1402877801X, 1402877804X, 1402959102X, 1402959201X, 1402959202X, 1402959204X, 1403031005X, 1403133802X, 1403133804X, 1403133805X, 1403353401X, 1403353402X, 1403353403X, 1403353404X, 1403353405X, 1403571101X, 1403571102X, 1403571103X, 1403571104X, 1403571105X, 1403701202X, 1403701203X, 1403701204X, 1403701205X, 1403701206X, 19941, 20214, 20349, 20381, 20585, 20652, 20702, 20714, 20722, 20781, 20832, 20862, 20878, 20878-2, 20879, 20933, 21017, 21019, 21032, 21104, 21171, 21173, 21

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0961-2019%22

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