Reported Apr 5, 2023 · Ongoing

Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT…

Alcon Research, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research, LLC · 9965 Buffalo Speedway · Houston, TX · 77054-1309

Alcon
Custom Pak Surgical Procedure PackPak
Number & Pak Description17533-04 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 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

Lot codes and dates: 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
158MHL 18023-04 10/31/2024 00380651661189
158P7W 17039-13 08/31/2024 00380651701229
158P97 5300-61 10/31/2024 00380651672659
Amount recalled: 1035 packs

Sterility; Steril surgical procedure packs contain incomplete seals.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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8 in total.