FDA Medical Device Recalls (openFDA)
Alcon Laboratories, Inc: AcrySof ReSTOR Intraocular Lens
- Recall number
- Z-0429-2007
- Recalling firm
- Alcon Laboratories, Inc
- Product
- AcrySof ReSTOR Intraocular Lens
- Status
- Terminated
- Initiated
- 2006-12-14
- Posted
- 2007-02-15
- Terminated
- 2008-04-09
- Reason
- Intraocular lenses exposed to extreme temperatures while in storage.
- Root cause
- Other
- Action
- The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
- Quantity
- 4 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model SN60D3, Serial numbers: 968290.039; 934317.012; 934317.013; and 948332.080.
- 510(k) numbers
- not on file
- PMA numbers
- ["P040020"]
- Product code
- MFK
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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