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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution see related information
Date Initiated by Firm July 27, 2021
Create Date October 05, 2021
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Contamac Ltd.
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