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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 Pak see related information
Date Initiated by Firm June 09, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1373-2022
Recall Event ID 90437
510(K)Number K880961  
Product Classification General surgery tray - Product Code LRO
Product Alcon Custom Pak Surgical Procedure Pack:
16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP

18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE

18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS

11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR

11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR

11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR

14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
Code Information Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6 
Recalling Firm/
Manufacturer		 Alcon Research, LLC
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact
713-668-9100
Manufacturer Reason
for Recall		 Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
FDA Determined
Cause 2		 Process control
Action On 06/09/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via overnight mail to customer informing them that specific lots of Alcon Custom Paks were manufactured containing latex gloves and were intended to contain non-latex gloves. Customers are instructed to: 1. Review your inventory to determine if you have any unused affected product within your facility. See Table above for affected Custom Pak. 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 information 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. For questions - contact Alcon Customer Service at 1-800-862-5266
Quantity in Commerce 320 kits
Distribution U.S.: AZ, CA, MO, and NY O.U.S.: None
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES
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