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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number ACU0T0
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. (b)(4).
 
Event Description
A health professional reported that a preloaded device was very stiff and jerky. The timing of the event and patient impact are unknown. The health professional exchanged the device and did not use it. Additional information has been requested.
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Event Description
New information received from the customer stating the event was before touching the patient. There was no delay as a new lens as used.
 
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Brand NameACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key8561955
MDR Text Key143671398
Report Number1119421-2019-00565
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberACU0T0
Device Lot Number12641998
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/29/2019 Patient Sequence Number: 1
Treatment
HEALON
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