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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

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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); Device Displays Incorrect Message (2591); Positioning Problem (3009)
Patient Problems Hemorrhage/Bleeding (1888); Visual Impairment (2138); Discomfort (2330)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. (b)(4).
 
Event Description
A surgeon reported that during an intraocular lens (iol) implant procedure, the proximal haptic entered the eye inversely complicating the correct position inside the capsular bag. The postoperative refractive result presented an error of one diopter spherical power. In a follow up, the surgeon reported the iol was inserted wrong into the patient's eye, and when he turned the lens it caused profuse bleeding. When the iol was apparently positioned, the surgeon left the lens implanted. The surgeon plans to use viscoelastic to turn the iol over and place it in the capsular bag. The surgeon reported if this cannot be done, he will remove the iol and replace it with another lens model. The surgeon reported the patient experienced discomfort due to anisometropia. The target refraction was -0. 75, but the patient was -3. 00 postoperatively.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The surgeon reported in a follow up that the iol is still implanted in the patient's eye, but the patient may have zonular dialysis. The surgeon reported a vitrectomy may be necessary during a second procedure. The patient also has an astigmatism that does not coincide with the cornea, and has many aberrations.
 
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).
 
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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 Key7655130
MDR Text Key112891771
Report Number1119421-2018-00843
Device Sequence Number0
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Home Health Aide
Type of Report Initial,Followup,Followup
Report Date 11/12/2018
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberAU00T0
Device Lot Number12527450
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 Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2017
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: 07/02/2018 Patient Sequence Number: 0
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