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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Custom Pak

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 Class 2 Device Recall Alcon Custom Paksee related information
Date Initiated by FirmMarch 10, 2023
Date PostedMarch 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1291-2023
Recall Event ID 91878
510(K)NumberK880961 
Product Classification General surgery tray - Product Code LRO
ProductAlcon 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 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
Code Information 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;
Recalling Firm/
Manufacturer		 Alcon Research, LLC
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information ContactKristen Kellerhals
817-551-4047
Manufacturer Reason
for Recall		Sterility; Steril surgical procedure packs contain incomplete seals.
FDA Determined
Cause 2		Employee error
ActionOn March 10, 2023 Alcon issued a "Urgent: Voluntary Medical Device Removal" letter to affected consignees. In addition to notifying consignees about the recall product, they ask consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. See table on page 1 for affected Custom Pak lots. 2. Segregate any unused affected product from your inventory. 3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak. 4. Fill out the attached Response Form , even if you have zero (0) units remaining in inventory and return the form to Alcon using the contact information provided on the form. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred. 6. In the event you have experienced adverse events or product quality issues related to this communication, please contact Alcon via web (https://notifeye.alcon.com), by email (msus.safety@alcon.com) or by phone (1-800-757-9780, Option 5). 7. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program either online (FDA EMAIL), by regular mail or by fax: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
Quantity in Commerce1035 packs
DistributionUS: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LRO
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