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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SV25T6
Device Problems Scratched Material (3020); Ejection Problem (4009)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
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 the manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that during an intraocular lens (iol) implant procedure, the lens was found to be scratched after implanting. The surgery was completed without product replacement. It was confirmed that the lens became sideways during insertion and was pushed by the plunger in that position, and the surface of the lens got scratched after being implanted into the patient's eye. Also, seems to be a problem at the time of setting, and there was evidence that instead of pushing the edge of the iol optic, the plunger pushed the surface of the optic. Additional information has been requested.
 
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Brand NameACRYSOF IQ RESTOR 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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12717542
MDR Text Key278995030
Report Number1119421-2021-02025
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P040020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSV25T6
Device Lot Number12595941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
Treatment
MONARCH II INJECTOR; MONARCH III CARTRIDGE D; OPEGAN-HI
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