Atlas FDA

Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision

FDA device recall Z-1402-06 · posted 2006-08-16 · Terminated

Recall details

Recalling firm
Ciba Vision Corporation
Reason for recall
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
Action taken
Consignees were notified by letter on/about 07/25/06 to return any of the affected lots found in inventory
Root cause
Other
Status
Terminated
Product code
LPL
Quantity affected
86 (approx 1000 lenses) packs total
Distribution
Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA.
Date initiated
2006-07-25
Date posted
2006-08-16
Date terminated
2006-12-27
Location
Duluth, GA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (K050065)Ciba Vision Corporation2005-05-27