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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 Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: 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 customer reported an intraocular lens (iol) was torn.The procedure was completed with a backup lens.Additional information was requested.
 
Manufacturer Narrative
The torn lens was found upon opening, therefore this is not a reportable malfunction.No additional reports will be submitted for this device.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 LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
MDR Report Key9770986
MDR Text Key184673686
Report Number9612169-2020-00073
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 other
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.135
Device Lot Number21253290
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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