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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Additional information was requested. (b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, when the surgeon attempted to inject the iol, the injector backed out of the wound and the lens was delivered onto the conjunctiva. The surgeon considered the inaccurate delivery to be an error in technique. There was no harm to the patient and another lens was implanted instead.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7077508
MDR Text Key93622299
Report Number1119421-2017-01386
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAU00T0
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2017 Patient Sequence Number: 1
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