Device recall

Z-1328-2021: Alcon Custom Ophthalmic Surgical Procedure Packs

FDA device recall · Class II · Alcon Research, LLC

Key facts

Recall number (Z-number) Z-1328-2021
Recall event 87307
Product Alcon Custom Ophthalmic Surgical Procedure Packs
Product code LRO
Recalling firm Alcon Research, LLC
Recall class Class II
Status Terminated
Termination date Jun 30, 2023
510(k) numbers K880961
FEI number 1000117501

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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

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