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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 Problems Conjunctivitis (1784); Endophthalmitis (1835); Inflammation (1932); Swelling (2091)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. 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. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that two days following a cataract extraction with an intraocular lens (iol) implant procedure, the patient was diagnosed with endophthalmitis. A vitreous cavity puncture injection + anterior chamber were performed. The following day a vitrectomy was performed. Eight days later, a vitreous cavity lavage, intraocular lens extraction and silicone oil filling were performed. Additional information was provided indicating that the patient had vitreous inflammation, conjunctival redness and swelling. Routine blood examination was performed. No infectious hemogram. A culture was performed. The event resulted in clinically significant visual change. The interventions performed were effective. The outcome of the event resolved. The patient recovered with persistent condition.
 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8761608
MDR Text Key150108734
Report Number1119421-2019-01050
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P930014
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 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Model NumberSN6AT6
Device Catalogue NumberSN6AT6.245
Device Lot Number12538614
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 Received08/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2017
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: 07/03/2019 Patient Sequence Number: 1
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