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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number SN6CWS
Device Problem Defective Device (2588)
Patient Problem Visual Impairment (2138)
Event Date 05/01/2022
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. A photo was provided which shows a yellow lens placed inside a the barrel of an ovd syringe. A note is visible in the photo with the patient information hand written on it. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported following an intraocular lens (iol) implant procedure, the patient complained several times postoperatively about poor visual acuity. As a result, surgeon decided to exchange the iol for the same type of lens and same diopter. The surgeon also suspects an irregularity on the anterior surface of the lens. Postoperative result was satisfactory. Additional information has been requested.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C 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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key14877069
MDR Text Key295065098
Report Number1119421-2022-01428
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSN6CWS
Device Catalogue NumberSN6CWS.185
Device Lot Number12750108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2022 Patient Sequence Number: 1
Treatment
ACRYSOF IOL W/ACRYSERT DELIVERY SYSTEM
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