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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Visual Impairment (2138)
Event Type  Injury  
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. Results from the product history record review indicated the product met release criteria. There has been one other complaint reported in the lot number. (b)(4).
 
Event Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced an unexpected postoperative outcome of -6. 00 diopters. The iol was exchanged for another lens with half a diopter less power three weeks following the initial implant procedure.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jason michaelides
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686438
MDR Report Key9514351
MDR Text Key172568954
Report Number1119421-2019-02196
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Model NumberAU00T0
Device Lot Number12726594
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2019
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: 12/23/2019 Patient Sequence Number: 1
Treatment
UNSPECIFIED DUOVISC VISCOELASTIC
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