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
Product summary
- 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
foreign material