Product Description
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Reason for Recall
Contact lens solution may contain foreign material
Action Details
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
Distribution Pattern
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
Code Information / Serial Numbers
Lot Number: FOE