Date Initiated by Firm |
May 25, 2022 |
Date Posted |
August 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1590-2022 |
Recall Event ID |
90336 |
510(K)Number |
K142284 K050729
|
Product Classification |
Accessories, soft lens products - Product Code LPN
|
Product |
a. 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 Contact |
Ms. 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 |
Action |
Mckesson 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 Commerce |
a. 3 b. 91 c. 45 d. 2 |
Distribution |
US Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
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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 = LPN and Original Applicant = ALCON LABORATORIES, INC. 510(K)s with Product Code = LPN and Original Applicant = ALCON RESEARCH, LTD.
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