• 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, LTD. - 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, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problem Discharge (2225)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
Product evaluation: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Additional information has been requested. (b)(4).
 
Event Description
A physician reported a wound leak following forceful introduction of a lens during an intraocular lens (iol) implant procedure. The physician reported that there was a lot of force required to introduce the lens. He stated that he did load and utilize the introducer as instructed, nevertheless there was that split at the junction between the optic and the haptic, which he had never seen before.
 
Manufacturer Narrative
This supplement is being filed to correct the value to adverse event and product problem. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Product evaluation: the product was not returned. The customer provided two serial numbers it is uncertain which lens is the complaint product. Product history records were reviewed for lot and the documentation indicated the product met release criteria. A qualified viscoelastic was indicated. The product investigation could not identify a root cause for the reported events. It was stated that damage was observed "split at the junction between the optic and the haptic". This may indicate the lens and/or plunger were not in acceptable positions for advancement. The dfu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics. The plunger should be in contact with the trailing optic edge. After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation. Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
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, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7868837
MDR Text Key119990403
Report Number1119421-2018-01352
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberAU00T0
Device Lot Number12608653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2018
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: 09/12/2018 Patient Sequence Number: 1
-
-