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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon

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 Class 2 Device Recall Alconsee related information
Date Initiated by FirmMay 25, 2022
Date PostedAugust 26, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1590-2022
Recall Event ID 90336
510(K)NumberK050729 K142284 
Product Classification Accessories, soft lens products - Product Code LPN
Producta. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution Model Number: 00065035610. d. Alcon Contact Lens Solution Opti Free Replenish 2 oz. Solution Model Number: 00065135658.
Code Information a. GTIN: 00047113609126 EA; 20300650358204 CS. All lots received between 7/4/21-9/30/21. b. GTIN: 00300650356350 EA; 20300650356354 CS All lots received between 7/4/21-9/30/21. c. GTIN: 00300650356107 EA; 20300650357207 CS All lots received between 7/4/21-9/30/21. d. GTIN: 00300651356380 EA, 20300650357399 CS All lots received between 7/4/21-9/30/21
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information ContactMs. Ruby Upadhyaya
804-553-2281
Manufacturer Reason
for Recall		Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA Determined
Cause 2		Environmental control
ActionMckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Quantity in Commercea. 3 b. 91 c. 45 d. 2
DistributionUS Nationwide
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 = LPN
510(K)s with Product Code = LPN
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