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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SV25T3
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Visual Impairment (2138)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The reporter called and does not know patient identification and says it was not an unexpected error that had occurred.
 
Manufacturer Narrative
Product evaluation: the product was not returned for analysis. The lens remains implanted. 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. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported an intraocular lens (iol) that was exchanged due to unexpected post-operative error, and poor vision especially at near.
 
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Brand NameACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7201409
MDR Text Key110212800
Report Number1119421-2018-00052
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Model NumberSV25T3
Device Catalogue NumberSV25T3U200
Device Lot Number12527607
Other Device ID NumberSV25T3U200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2017
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: 01/17/2018 Patient Sequence Number: 1
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