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FDA Medical Device Recalls (openFDA)

Ciba Vision Corporation: 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 number
Z-0847-05
Recalling firm
Ciba Vision Corporation
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.
Status
Terminated
Initiated
2005-04-21
Posted
not on file
Terminated
2005-10-21
Reason
The actual power of the lenses may be different from what is indicated on the package labeling.
Root cause
Other
Action
Consignees were notified via traceable mail on April 21, 2005.
Quantity
2250 units
Distribution
Nationwide, Europe
Lot, serial or model codes
Lot #124637
510(k) numbers
not on file
PMA numbers
not on file
Product code
LPL
Firm FEI
1053053
Firm city
Duluth
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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