FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: Opthalmic Laser, product number 8065-5000-1
- Recall number
- Z-0923-04
- Recalling firm
- Alcon Research, Ltd.
- Product
- Opthalmic Laser, product number 8065-5000-1
- Status
- Terminated
- Initiated
- 2004-04-09
- Posted
- 2004-07-20
- Terminated
- 2004-08-30
- Reason
- Product may generate laser light flashback.
- Root cause
- Other
- Action
- Additional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004.
- Quantity
- 62
- Distribution
- Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.
- Lot, serial or model codes
- None
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- not on file
- 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