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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SND1T4
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Blurred Vision (2137); Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative
The device was received by a company representative and is in process to transit to the manufacturing site for investigation. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Product history records were reviewed and documentation indicated the product met release criteria. There have been no other complaints in the lot. Additional information was requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported that after an intraocular lens (iol) was implanted, the patient experienced headache, dizziness and glare in near vision. The lens was exchanged for another lens of a different model and. 5 diopters stronger power. Additional information was requested.
 
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Brand NameACRYSOF 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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key8135060
MDR Text Key129433499
Report Number1119421-2018-01717
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P040020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Model NumberSND1T4
Device Catalogue NumberSND1T4.255
Device Lot Number12449297
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 Received09/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2016
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: 12/05/2018 Patient Sequence Number: 1
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