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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 AU00T0
Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 09/21/2022
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided by the reporter for further investigation.There have been no manufacturing changes with the company device.No determination can be made without physical evaluation of the sample.The reporter has indicated they do not want to provide any further information.The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the intraocular lens tore minimally when injected into the patient's eye.It seemed to doctor that it was slightly different in appearance and a little harder to inject the intraocular lens.Something was strange and the distal haptic did not appear to position itself in the usual way.Additional information was requested, but further no information was available.
 
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Brand Name
ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of Device
INTRAOCULAR 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 Key15622828
MDR Text Key303268398
Report Number1119421-2022-02206
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAU00T0
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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