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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 INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM INTRAOCULAR LENS Back to Search Results
Model Number AUL0T0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/10/2021
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 have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that following an intraocular lens (iol) implant procedure, postoperative cell increase was confirmed to the patient. In a steroid responder patient, steroid eye drop was instilled, and the intraocular pressure increased. Therefore, steroid treatment was discontinued. Anti-inflammatory drop treatment was started because the number of cells increased. Additional information has been requested. There are two medical device reports associated with this patient. This report is associated with the right eye.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceINTRAOCULAR LENS
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 Key13249990
MDR Text Key283750127
Report Number1119421-2022-00077
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAUL0T0
Device Lot Number15102461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/13/2022 Patient Sequence Number: 1
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