FDA Medical Device Recalls (openFDA)
Alcon Research LLC: Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
- Recall number
- Z-1794-2020
- Recalling firm
- Alcon Research LLC
- Product
- Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
- Status
- Terminated
- Initiated
- 2018-07-25
- Posted
- not on file
- Terminated
- 2020-04-24
- Reason
- There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
- Root cause
- Employee error
- Action
- The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.
- Quantity
- 102 packs
- Distribution
- There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
- Lot, serial or model codes
- Lot #2128524H
- 510(k) numbers
- ["K101285"]
- PMA numbers
- not on file
- Product code
- HQC
- 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