FDA Recall Terminated

Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses.

Recall: Z-0847-05 · Initiated April 21, 2005

Recall

Recall Number
Z-0847-05
Event Number
31864
Firm
Ciba Vision Corporation
FEI Number
1053053
Product Code
LPL
Status
Terminated
Root Cause
Other
Initiated
April 21, 2005
Terminated
October 21, 2005
Address
11460 Johns Creek Pkwy, Duluth, GA, 30097-1518

Description

Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been distributed in twin packs containing six pairs of lenses.

Reason

The actual power of the lenses may be different from what is indicated on the package labeling.

Action

Consignees were notified via traceable mail on April 21, 2005.

Distribution

Nationwide, Europe

Quantity

2250 units