FDA Medical Device Recalls (openFDA)
American Optisurgical Inc: American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
- Recall number
- Z-1808-2009
- Recalling firm
- American Optisurgical Inc
- Product
- American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
- Status
- Terminated
- Initiated
- 2009-03-24
- Posted
- 2009-09-04
- Terminated
- 2009-09-04
- Reason
- Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.
- Root cause
- Software change control
- Action
- American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.
- Quantity
- 12 units
- Distribution
- Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.
- Lot, serial or model codes
- Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129.
- 510(k) numbers
- ["K020527"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 1000135560
- Firm city
- Lake Forest
- Firm state
- CA
- 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