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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested.(b)(4).
 
Event Description
An ophthalmologist reported that following an intraocular lens (iol) implant procedure, the patient experienced decreased acuity.The iol was exchanged for another lens two and a half months following the initial procedure.Additional information has been requested.
 
Manufacturer Narrative
Additional information provided in b.3., b.6., b.7.And d.11.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ TORIC SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key9533780
MDR Text Key173173282
Report Number1119421-2019-02224
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model NumberSN6AT6
Device Catalogue NumberSN6AT6U230
Device Lot Number12588757
Was Device Available for Evaluation? No
Date Manufacturer Received12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORA ABERROMETER 195.5, 8065998326, ITC.
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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