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.

Terminated

RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

FDA Recall Z-1340-2012 · Posted 2012-03-30

Recalling FirmOptovue Inc.
Recall StatusTerminated
Product CodeOBO
Date Initiated2012-02-21
Date Terminated2012-04-02
Product Quantity8

Reason for Recall

A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.

Firm Action

Field Correction letters were sent to all doctors affected by the issue on February 23, 2012. The letter identified the affected product and the problem. The letter also stated that customers may continue to use the RTVue until the correction was made. Once the correction has been made, customers are to sign and return the attached acknowledgement form. If customers had questions, they are to contact Optovue at 1-866-344-8948 or via mail at 45531 Northport Loop W, Fremont, CA 94538.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution -- CA and WA only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111505RTVUE CAM WITH CORNEAL POWER UPGRADEOptovue, Inc. · 2011-09-08

Official Source

View FDA Recall →

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

↑