RecallRadar

FDA Device recall Z-1200-2023

CustomEyes kits

On 2023-03-08 the FDA classified a Class II recall of CustomEyes kits by Beaver Visitec International, citing device packaging may contain open seals, compromising product sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1200-2023
ClassificationClass II
Statusongoing
Initiated2022-12-20
Published2023-03-08
Last updated2026-09-13 11:56 UTC
CompanyBeaver Visitec International
DistributionAL, 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, WI

Product

CustomEyes kits

Reason

Device packaging may contain open seals, compromising product sterility.

Identifiers

code_infoCatalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.