• 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 W/ACRYSERT C 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 W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number SN6CWS
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A health professional reported that after an intraocular lens (iol) implant surgery, the surgeon noticed the wrong strength of lens was implanted. A 6. 0 diopter lens was implanted when it should have been a 12. 5 diopter lens. The lens was removed on a secondary surgery and a new lens was implanted. The patient impact has been resolved. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jason michaelides
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686438
MDR Report Key9513064
MDR Text Key172580748
Report Number1119421-2019-02190
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model NumberSN6CWS
Device Catalogue NumberSN6CWS.125
Device Lot Number12393175
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 Received02/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2015
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: 12/23/2019 Patient Sequence Number: 1
-
-