American Optisurgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What American Optisurgical, Inc. makes
American Optisurgical, Inc. manufactures phacoemulsification systems and associated disposables for cataract surgery, including reusable and disposable components like the AOI LC-40, Horizon HZN-2030, and Visual 551 systems. Their portfolio also includes tissue removal tools such as the TX1 system and its disposable packaging (DM001). These devices are designed for ultrasonic emulsification and aspiration of the eye’s natural lens.
The company’s products are regulated under FDA’s Class II and Unclassified (U) device categories, with most cleared via the 510(k) pathway. They are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Aoi Lc-40 Phacoemulsifier Ref K952331
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
RM001 Reusable Ref K953538
Regimes: 510(k) Registry: 510(k)TX1 Tissue Removal System Ref K101561
Regimes: 510(k) Registry: 510(k)DM001 Disposable Pack Ref K953539
Regimes: 510(k) Registry: 510(k)Visual Phacoemulsification System, Model 551 Ref K080803
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by American Optisurgical, Inc., the earliest on 2009-03-24 and the most recent on 2013-04-30. By recorded status: 5 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 30 Apr 2013 Z-1505-2013 Class II Terminated American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual
unit packaging.
Full distribution text
- 30 Apr 2013 Z-1518-2013 Class II Terminated American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
Full distribution text
- 30 Mar 2013 Z-1516-2013 Class II Terminated The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
Full distribution text
- 30 Apr 2013 Z-1505-2013 Class II Terminated American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual
unit packaging.
2012
- 22 Feb 2012 Z-1817-2012 Class II Terminated Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
2009
- 24 Mar 2009 Z-1808-2009 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does American Optisurgical, Inc. have in the registry?
The registry currently lists 6 devices for American Optisurgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Optisurgical, Inc.'s devices?
Among its 6 most recently registered devices, American Optisurgical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do American Optisurgical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for American Optisurgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for American Optisurgical, Inc.?
FDA recall records list 5 recalls initiated by American Optisurgical, Inc., the most recent initiated on 30 Apr 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from American Optisurgical, Inc. in the registry?
The most recently registered devices listed for American Optisurgical, Inc. include AOI LC-40 PHACOEMULSIFIER, HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030, RM001 REUSABLE and TX1 TISSUE REMOVAL SYSTEM.