Class 2 Device Recall Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution

• Date Initiated by Firm: July 27, 2021
• Create Date: October 05, 2021
• Recall Status: Terminated on June 07, 2023
• Recall Number: Z-0030-2022
• Recall Event ID: 88529
• 510(K)Number: K181566
• Product Classification: Products, contact lens care, rigid gas permeable - Product Code MRC
• Product: Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
• Code Information: Lot Number: FOE
• Recalling Firm/ Manufacturer: Contamac Solutions, Inc.; 806 Kimball Ave; Grand Junction CO 81501-3842
• For Additional Information Contact: Contamac Customer Service; 833-266-8262
• Manufacturer Reason for Recall: Contact lens solution may contain foreign material
• FDA Determined Cause: Device Design
• Action: On 8/5/2021, Contamac, issued a "Urgent: Medical Device recall" notification to affected consignees. In addition to informing consignees about the recall product, Contamac asked consignees to take the following actions: 1. Refer to the package label and Product Distribution Information below to verify the product is impacted (i.e. lot FOE). 2. Immediately discontinue use of impacted product 3. Destroy and discard the product (i.e. remove vial cap and empty contents before discarding) 4. Notify us using the following link to confirm that you received this recall notification and have discarded impacted product: Customer Form 5. If you have questions, please contact Toll-Free: 1-833-266-8262, Telephone: 1-970-985-4240, E-Mail: hello@nutrifill.com, Hours: M-F 9:00 am - 5:00 pm MDT 6. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA: Online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm or, Call FDA 1-800-FDA-1088
• Quantity in Commerce: 104335 vials
• Distribution: US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. OUS: N/A
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MRC