Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Unintended Ejection (1234); Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported during the intraocular lens implantation the lens could not be properly folded and was not advanced completely.There was patient contact.The surgery was completed after replacing the product with another one.There was no harm to the patient.Additional information has been requested and received stating there was no postoperative inflammation or complications.The patient visual acuity has improved and there were no health problems.
 
Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported during the intraocular lens implantation the lens could not be properly folded and was not advanced completely.There was patient contact.The surgery was completed after replacing the product with another one.There was no harm to the patient.Additional information has been requested and received stating there was no postoperative inflammation or complications.The patient visual acuity has improved and there were no health problems.
 
Event Description
Additional information was received stating there was patient contact.The lens inserted and removed from the eye during the surgery.
 
Manufacturer Narrative
The device and the lens were returned inside the opened blister tray in the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.No damage was observed to the device.The lens was returned adhered in dried viscoelastic to the interior of the opened blister tray.Viscoelastic and blood were observed dried on the lens.The optic has a cracked area on the posterior surface near the edge.The lens was cleaned with klrp for further evaluation.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A non-qualified viscoelastic was indicated.The lens was returned outside of the device.A small cracked optic area was observed.A fold test was conducted with no difficulty.The root cause for the complaint of "iol could not properly folded and could not be advanced completely" may be related to a failure to follow the ifu.A non-qualified viscoelastic was indicated.The instructions for use instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device should be used.The use of an unqualified viscoelastic may cause damage to the lens and potential complications during the device preparation and implantation steps.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of Device
LENS, 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
8007579780
MDR Report Key13634733
MDR Text Key286337632
Report Number1119421-2022-00369
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 Physician
Type of Report Initial,Followup
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2023
Device Model NumberAU00T0
Device Lot Number15123593
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HYALURONATE NA OVD-SENJYU
-
-