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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

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ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis.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 non-healthcare professional reported an explanted intraocular lens, with a patient reason for explant of "unhappy with vision", and a clinical reason for explant of "refractive surprise".Additional information has been requested.
 
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Brand Name
ACRYSOF IQ TORIC SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI   00000
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10876520
MDR Text Key217424446
Report Number9612169-2020-00231
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.190
Device Lot Number21238297
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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