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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 8065741076
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Patient Involvement (2645)
Event Date 09/06/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the system had incorrect readings/values due to a physically damaged probe. There was no patient impact and another system was used to complete surgeries. The company service representative examined the system and replaced the damaged probe with a new probe. The system was then tested and met all product specifications. The system was manufactured on september 18, 2003. Based on qa assessment, the product met specifications at the time of release. The root cause cannot be determined conclusively. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
 
Event Description
A customer reported that the diagnostic readings are incorrect. This occurred prior to a surgical procedure therefore there was no patient involvement.
 
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Brand NameOCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6999192
MDR Text Key149364418
Report Number2028159-2017-04196
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K844686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8065741076
Other Device ID Number1.12
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/03/2017 Patient Sequence Number: 1
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