Z-1808-2009

American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery

Name: Z-1808-2009 American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery
Creator: American Optisurgical Inc
Published: 2009-03-24
License: https://open.fda.gov/license/

Tenex Health / initiated 2009-03-24 / Terminated / root cause: software

FDA source

American Optisurgical Inc began a recall of American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery on 2009-03-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1808-2009
Status: Terminated
Initiated: 2009-03-24
Posted: 2009-09-04
Terminated: 2009-09-04
Recalling firm: Tenex Health
Product: American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
Product code: HQC Unit, Phacofragmentation
Reason for recall: 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 tag: software
FDA 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 in commerce: 12 units
Distribution: Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.
Product codes and lots: Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129.

Product code HQC

K020527Class IIHorizon Phacoemulsification System, Model Hzn-2030American Optisurgical, Inc. / cleared 2002-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)