FDA Medical Device Recalls (openFDA)
Alcon Research, LTD.: Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
- Recall number
- Z-0779-2018
- Recalling firm
- Alcon Research, LTD.
- Product
- Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
- Status
- Terminated
- Initiated
- 2018-01-12
- Posted
- not on file
- Terminated
- 2022-02-04
- Reason
- Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
- Root cause
- Employee error
- Action
- Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.
- Quantity
- 52 units
- Distribution
- Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
- Lot, serial or model codes
- Lot 507492, 507664, 507539
- 510(k) numbers
- ["K101285"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 1000117501
- Firm city
- Houston
- 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