Enuclene Ophthalmic Solution

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Enuclene(R) Ophthalmic Solution

Trade Name

Enuclene Cleaning/Lubricating Solution

Generic Name

Solution, cleaning / lubricating, artificial eye

PMA Number

N13787 ↗

FDA Product Code

MSI

Device Class

Class III

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

• Alcon Multi-Purpose Disinfecting Solution Open recall

  Class II

  FDA 510(k) K050729 Active Cleared 14 Sep 2005

• Ladarwave Customcornea Wavefront System

  Class I

  FDA 510(k) K062930 Active Cleared 8 Nov 2006

• Clearcut S Safety Knife Open recall

  Class I

  FDA 510(k) K110166 Active Cleared 20 May 2011

• CENTURION Vision System (Active SentryTM)

  Class II

  FDA 510(k) K161794 Active Cleared 14 Apr 2017

• Monarch II IOL Delivery System

  Class I

  FDA 510(k) K001157 Active Cleared 27 Jun 2000

• Wavelight FS200 Laser System Model: FS200

  Class II

  FDA 510(k) K101006 Active Cleared 21 Oct 2010

See all devices from Alcon Research, Ltd. →