FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
- Recall number
- Z-0195-2016
- Recalling firm
- Alcon Research, Ltd.
- Product
- Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
- Status
- Terminated
- Initiated
- 2015-09-21
- Posted
- 2015-10-30
- Terminated
- 2016-03-24
- Reason
- The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
- Root cause
- Mixed-up of materials/components
- Action
- The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.
- Quantity
- 5 units
- Distribution
- Distributed in VT.
- Lot, serial or model codes
- 1792733H, 1783925H, 1785227H, 1786729H
- 510(k) numbers
- ["K880961"]
- PMA numbers
- not on file
- Product code
- LRO
- 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