The Recall Desk
HighFDA (Devices)·Z-1291-2023·Announced 2023-04-05

Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

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: This is an FDA Class II medical device recall involving surgical procedure packs with incomplete seals affecting sterility. Although no illnesses or injuries have been reported, this is a risk-of-harm product used in surgical procedures where sterility is critical to prevent complications.

Plain-English summary

Alcon Research, LLC is recalling 1,035 Custom Pak Surgical Procedure Packs. The affected packs are used in surgical procedures, including cataract and ophthalmic surgeries at ambulatory surgery centers and hospitals throughout the United States.

The recalled packs contain incomplete seals, which compromises the sterility of the medical instruments and materials inside. Incomplete seals can allow the sterile condition to be lost during storage and handling before use in surgery.

The affected packs were distributed to surgical facilities in Alabama, Arkansas, California, Iowa, Idaho, Indiana, Kentucky, Minnesota, North Carolina, North Dakota, New Jersey, Ohio, Pennsylvania, and Texas. The recalled packs include multiple lot numbers with expiration dates ranging from April 2024 to December 2024.

Healthcare facilities receiving these packs should immediately stop using them and quarantine all affected units. Facilities should contact Alcon Research for guidance on replacement products and disposal of the recalled packs.

The recalled product

Product
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
Manufacturer
Alcon Research, LLC
Category
Medical Device — Surgical Procedure Pack
Hazard
  • incomplete-seal
  • sterility-compromise

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 (20)

  • Lot #-Pack #-Expiry Date - UDI: 158JNA 17533-04 9/30/2024 00380655132814
  • 158L18 18704-03 12/31/2024 00380651672833
  • 158JNN 18382-03 10/31/2024 00380655117132
  • 158L27 8685-21 09/30/2024 00380655142486
  • 158L24 19451-02 09/30/2024 00380655143995
  • 158L44 19136-03 12/31/2024 00380655129975
  • 158HU3 18401-03 04/30/2024 00380651651487
  • 158MH8 16032-05 12/31/2024 00380653369250
  • 158L5X 17570-05 10/31/2024 00380655129227
  • 158NEX 19002-02 10/31/2024 00380655120231
  • 158MJ3 10560-14 12/31/2024 00380655136317
  • 158NE8 16877-11 12/31/2024 00380655116579
  • 158NDK 19061-02 08/31/2024 00380655118504
  • 158NEM 18911-02 04/30/2024 00380651691940
  • 158PCP 17469-02 08/31/2024 00380653377156
  • 158PCD 18917-01 09/30/2024 00380651677333
  • 158P8K 17115-06 07/31/2024 00380651698079
  • 158NDC 17780-04 12/31/2024 00380651682719
  • 158N9Y 2452-58 12/31/2024 00380653403589
  • 158MFC 19096-01 10/31/2024 00380651696235

Distribution

Distributed in 14 states:

  • AL
  • AR
  • CA
  • IA
  • ID
  • IN
  • KY
  • MN
  • NC
  • ND
  • NJ
  • OH
  • PA
  • TX

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