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FDA Medical Device Recalls (openFDA)

Ciba Vision Corporation: CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.

Recall number
Z-0793-2007
Recalling firm
Ciba Vision Corporation
Product
CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.
Status
Terminated
Initiated
2007-04-30
Posted
2007-05-09
Terminated
2008-03-13
Reason
Base curve of the lenses do not meet specification.
Root cause
Other
Action
Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.
Quantity
22 lenses
Distribution
Nationwide.
Lot, serial or model codes
Lot #41074100201110
510(k) numbers
not on file
PMA numbers
["P820086"]
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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