FDA Medical Device Recalls (openFDA)
Ocular Sciences, Inc.: Sunsoft Multiples Toric, methafilcon A, clear contact lens.
- Recall number
- Z-0348-05
- Recalling firm
- Ocular Sciences, Inc.
- Product
- Sunsoft Multiples Toric, methafilcon A, clear contact lens.
- Status
- Terminated
- Initiated
- 2004-12-09
- Posted
- 2004-12-23
- Terminated
- 2005-03-31
- Reason
- Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
- Root cause
- Other
- Action
- All consignees were notified by courier on 12/09/2004.
- Quantity
- 46 lenses
- Distribution
- AR, AZ, CA, DC, GA, MI, MO, MS, NJ, NM, OR, PA, TN, TX, WI. No government, military or foreign distribution.
- Lot, serial or model codes
- Lot Number 12981729
- 510(k) numbers
- ["K964696"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 1629558
- Firm city
- Albuquerque
- Firm state
- NM
- 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