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FDA Medical Device Recalls (openFDA)

Bausch & Lomb Inc: Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz

Recall number
Z-0715-2007
Recalling firm
Bausch & Lomb Inc
Product
Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz
Status
Terminated
Initiated
2007-03-05
Posted
2007-04-04
Terminated
2008-01-09
Reason
A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
Root cause
Other
Action
The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.
Quantity
1.5 million units
Distribution
Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.
Lot, serial or model codes
Lot numbers appearing on the bottles distributed in the U.S.: GC6030, GC6037, GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration date ''2008-03'' on the bottle.   Lot numbers appearing on bottles distributed only outside of the U.S.: GC6038, GC6048 and GC6052.
510(k) numbers
["K020802"]
PMA numbers
not on file
Product code
LYL
Firm FEI
1317628
Firm city
Rochester
Firm state
NY
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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