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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 Material Split, Cut or Torn (4008)
Patient Problem Corneal Edema (1791)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. 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. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that during an intraocular lens (iol) implant procedure, the haptic and optic were torn, so we exchanged it. The patient had a prolonged case, and has a lot of corneal edema. Additional information was provided by the physician that the plunger has excessive lateral mobility that captured the iol haptic and iol optic. The sharp edges of plunger applied excessive force on the iol optic and iol haptic and caused it to be damaged. The visualization during the delivery process is not optimal to determine if the iol is going to become entrapped or captured by the plunger. The surgical intervention needed initially was removal of the damaged intraocular lens implant by first removing the iol from the capsular bag, next cutting the iol in 3 pieces, last to remove the iol pieces. The patient has been followed closely by both our facility and the cornea specialist in the community. The patient needed a corneal procedure called descemet's stripping endothelial keratoplasty (dsek) due to the inability for his corneal edema to resolve. As you know corneal edema increases with surgical time and manipulation of the eye. His surgical time was 88 minutes. The surgery was performed by a chief resident from university of (b)(6) with an attending assisting during the complex steps.
 
Manufacturer Narrative
Product evaluation: the product was not returned. Product history records were reviewed and the documentation indicated the product met release criteria. A non-qualified viscoelastic was indicated. The root cause may be related to a failure to follow the directions for use (dfu). As stated dfu, only qualified viscoelastics must be used in conjunction with the device. All other viscoelastics are not qualified for use. (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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8095584
MDR Text Key128113679
Report Number1119421-2018-01645
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberAU00T0
Device Lot Number12557516
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 Received01/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2017
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: 11/21/2018 Patient Sequence Number: 1
Treatment
ENDOCOAT
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