Z-0847-05

Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only *...

Name: Z-0847-05 Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only *...
Creator: Ciba Vision Corporation
Published: 2005-04-21
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2005-04-21 / Terminated / root cause: labeling and UDI

FDA source

Ciba Vision Corporation began a recall of Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * Ciba Vision, Duluth, GA. The product has been... on 2005-04-21. The reason FDA records is "The actual power of the lenses may be different from what is indicated on the package labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0847-05
Status: Terminated
Initiated: 2005-04-21
Posted: 2015-06-25
Terminated: 2005-10-21
Recalling firm: Alcon Laboratories
Product: 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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: The actual power of the lenses may be different from what is indicated on the package labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via traceable mail on April 21, 2005.
Quantity in commerce: 2250 units
Distribution: Nationwide, Europe
Product codes and lots: Lot #124637

Product code LPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)