ClearanceBrief
Recall Z-1590-2022 ยท LPN Accessories, Soft Lens Products

Mckesson Medical-Surgical Inc. Corporate Office

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 Repl

DateAug 26, 2022 (initiated May 25, 2022)
StatusOpen, Classified
ReasonFacility 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.
Root causeEnvironmental 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 pr
Quantitya. 3 b. 91 c. 45 d. 2
DistributionUS Nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050729ALCON MULTI-PURPOSE DISINFECTING SOLUTION
Alcon Research, Ltd., Sep 14, 2005
K142284CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
Alcon Laboratories, Inc., Jan 26, 2015