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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem Failure of Implant (1924)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
The product 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 has been requested. (b)(4).
 
Event Description
A surgeon reported a damaged optic edge of a lens in a preloaded device that was implanted during an intraocular lens (iol) implant procedure. Upon iol implantation it became obvious that the surgeon had not primed the device into the ready mode and simply injected the iol straight away. Upon review of the iol it was seen that the optic edge had become damaged. The lens remains implanted. After case completed surgeon indicated they had only used this device once before and had limited experience.
 
Manufacturer Narrative
Product evaluation: a qualified viscoelastic was indicated. The product investigation could not identify a root cause for the reported complaint. Not enough information was provided from the account for further investigation. Surgeon indicated they had only used the device once before and had limited experience. Surgeon did not ask the attending (clinical applications specialist) cas how to use the device. Cas indicated the device was not primed properly before use. The manufacturer internal reference number is: (b)(4).
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH 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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7648142
MDR Text Key112887630
Report Number1119421-2018-00833
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAU00T0
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
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: 06/28/2018 Patient Sequence Number: 1
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