Device recall

Z-0304-2026: Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity…

FDA device recall · Class II · Alcon Research LLC

Key facts

Recall number (Z-number) Z-0304-2026
Recall event 97415
Product Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+…
Product code MLZ
Recalling firm Alcon Research LLC
Recall class Class II
Status Open, Classified
510(k) numbers K141065, K233876, K242184
FEI number 1610287

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)