FDA recall Z-1200-2023

Beaver Visitec International, Inc. · Class II · device

Product

CustomEyes kits

Reason for recall

Device packaging may contain open seals, compromising product sterility.

Distribution

US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

Key facts

Status: Ongoing
Initiation date: 2022-12-20
Report date: 2023-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2023