The Recall Desk
HighFDA (Devices)·Z-2110-2025·Announced 2025-07-16

Alcon Custom Pak Surgical Packs Recalled for Potential Sterility Compromise

Alcon Custom Pak sterile surgical procedure packs are being recalled because some units may have damage to the packaging's lid area, which could compromise sterility. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for sterile surgical packs where visible damage to packaging could compromise sterility. Although no illnesses or injuries have been reported, the potential for post-operative infection from compromised sterility of surgical instruments justifies High severity as a risk-of-harm medical device.

Plain-English summary

Alcon Custom Pak sterile surgical procedure packs are being recalled because some units may have sustained damage during manufacturing in the packaging's lid area. These packs are custom-designed sterile surgical kits containing ophthalmic surgical instruments and materials, intended for use by trained eye surgeons.

The recall encompasses 15,557 kits distributed worldwide, including across the United States and to numerous international locations. Visible damage has been detected in the lidding of units within specific lots. Although the damage is visibly noticeable, the primary risk is potential compromise of sterility.

Healthcare facilities and surgical centers that have received affected Custom Pak units should check the lot numbers and UDI codes provided in the recall notice to determine if they have affected inventory. No illnesses or injuries from this issue have been reported to date.

The recalled product

Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgical Packs
Hazard
  • sterility-compromise
  • packaging-damage
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • ST JOHN'S 380655116074 14540-08 177H6V CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 178DYX CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 178FDJ CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 17AC44 CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 17AE5U CDN-CVS VIT 10K 25G+ HSC
  • W_O SLIT) KITANO HO 380655198353 17923-05 17CH88 J-CVS CAT PAK (W_IA
  • W_O SLIT) KITANO HO 380655199688 19037-05 17C991 J-COMB 25G20K (W_IA

Distribution

Distributed nationwide across the United States.

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