• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the device with the lens was returned. The plunger is oriented correctly. Inadequate viscoelastic is observed in the device. The plunger has been advanced under the lens. The lens is advanced almost to the fill line. The trailing haptic is misfolded under the optic. The nozzle was removed and cleaned for further evaluation. The lens was removed during cleaning. Top coat dye stain testing was conducted with acceptable results. All product and batch history records are quality reviewed prior to product release. Viscoelastic was not provided. It is unknown if the qualified product was used. A plunger underride was observed. The root cause may be related to a failure to follow the directions for use. Inadequate viscoelastic was observed in the device. There are no other complaints in this lot. The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implantation procedure, the iol would not deploy and the haptic went sideways. There was patient contact. Additional information was provided indicating felt resistance during injection. No damage to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10246277
MDR Text Key198690066
Report Number1119421-2020-00951
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAU00T0
Device Lot Number12738805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-