Device recall

Z-0631-2013: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

FDA device recall · Class II · Cooper Vision Caribbean Corp.

Key facts

Recall number (Z-number) Z-0631-2013
Recall event 63719
Product AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Product code LPL
Recalling firm Cooper Vision Caribbean Corp.
Recall class Class II
Status Terminated
Termination date May 9, 2014
510(k) numbers K113759
FEI number 3002911336

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)