Z-1590-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- May 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 3 b. 91 c. 45 d. 2
Product Description
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.
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.
Distribution Pattern
US Nationwide
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