Food, drugs, devices › American Optisurgical Inc
Device recall: American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in s
FDA enforcement event 65113 is a device recall by American Optisurgical Inc of Lake Forest, CA, initiated 30 Mar 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 24 Mar 2014. Initiation: voluntary: firm initiated. American Optisurgical Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Optisurgical Inc, Lake Forest, CA.
Reason for recall
"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"
Distribution
"Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1516-2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. | 194 units | Class II | Terminated | 12 Jun 2013 |
Context
Other enforcement events for American Optisurgical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Apr 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in su | Device | Class II | 1 |
| 30 Apr 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | Device | Class II | 1 |
| 22 Feb 2012 | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and r | Device | Class II | 1 |
All 4 events for American Optisurgical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Mar 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.