Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

CustomEyes kits

FDA Recall Z-1200-2023 · Posted 2023-03-01

Recalling FirmBeaver Visitec International, Inc.
Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2022-12-20
Product Quantity4640 units in total

Reason for Recall

Device packaging may contain open seals, compromising product sterility.

Firm Action

A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to [email protected].

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑