Z-0030-2022Class II

Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative...

Name: Z-0030-2022 Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative...
Creator: Contamac Solutions, Inc.
Published: 2021-07-27
License: https://open.fda.gov/license/

Contamac Solutions, Inc. / initiated 2021-07-27 / Terminated / root cause: design

FDA source

Contamac Solutions, Inc. began a recall of Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml)... on 2021-07-27. FDA classified it as Class II and gives the reason as "Contact lens solution may contain foreign material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0030-2022
Classification: Class II
Status: Terminated
Initiated: 2021-07-27
Posted: 2021-10-05
Terminated: 2023-06-07
Recalling firm: Contamac Solutions, Inc.
Product: Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Product code: MRC Products, Contact Lens Care, Rigid Gas Permeable
Reason for recall: Contact lens solution may contain foreign material
Root cause tag: design
FDA root 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: [email protected], 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
Product codes and lots: Lot Number: FOE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0030-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0030-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-05

Product code MRC

K181566Class IINutrifillContamac, Ltd. / cleared 2018-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)