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Recall Observatory FDA recall evidence

Device product

Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

Z-0030-2022

July 27, 2021

Class II

Product summary

Firm
Contamac Solutions, Inc.
Event
Event 88529
Status
Terminated
Classification
Class II
Quantity
104335 vials
Official record key
device-enforcement:Z-0030-2022

Official wording

Reason: Contact lens solution may contain foreign material

Code information: Lot Number: FOE

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign material