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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 Problem Positioning Problem (3009)
Patient Problems Visual Impairment (2138); Capsular Bag Tear (2639)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There are no other complaints in the lot. Additional information was requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that during an intraocular lens (iol) implant procedure, the lens jolted out of the preloaded injector and caused a tear in the posterior capsular bag. The surgeon left the lens implant thinking it was stable, although during the postoperative period the patient developed diplopia and the lens was noted to be decentered. The surgeon's assistant verified that two weeks after initial implantation, the lens was exchanged for a three piece lens instead.
 
Manufacturer Narrative
The product was returned for analysis. 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
In a follow up, the surgeon indicated that he thinks that an improper folding of the lens was to blame for the event.
 
Manufacturer Narrative
Only the lens was returned. Solution and what appears to be dried blood was observed on the lens. The optic is torn from the edge travelling across the optic toward the opposite edge. The device was not returned. Product history records were reviewed and the documentation indicated the product met release criteria. A qualified viscoelastic was indicated. The root cause for the complaint cannot be determined. The device was not returned for an evaluation. Only the explanted lens was returned. Damage was observed to the optic. It cannot be confirmed if the lens was in a proper position for advancement during delivery. Information was provided by an hcp that the lens was removed and replaced with a 3- piece replacement iol. Reason for removal - the patient developed diplopia due to decenter lens. The manufacturer internal reference number is: 2018-77876.
 
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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
MDR Report Key8058484
MDR Text Key126886783
Report Number1119421-2018-01593
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 health professional
Type of Report Initial,Followup,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberAU00T0
Device Lot Number12609785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/11/2018 Patient Sequence Number: 1
Treatment
PROVISC
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