Device Recall BioEye 의 리콜

Recall

36298

Class 3

Z-0012-2007

2006-02-27

2006-10-04

Terminated

United States

2006-10-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48367

The end label on the outer box was mislabeled on 9 of a 10 unit lot. the end label says ''22 mm'' and the implants are actually ''20 mm''. the main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.

The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.