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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 SN6AT5
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The results from the product history record review indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. Attempts have been made to obtain additional information. (b)(4).
 
Event Description
A facilities representative reported that following an intraocular lens (iol) implant procedure, it was discovered that an incorrect power/diopter was implanted. The iol was exchanged in a secondary procedure. Additional information was requested.
 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, 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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6830604
MDR Text Key83979583
Report Number9612169-2017-00169
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 other
Reporter Occupation
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Model NumberSN6AT5
Device Catalogue NumberSN6AT5.150
Device Lot Number21170155
Other Device ID Number00380652250894
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2016
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: 08/30/2017 Patient Sequence Number: 1
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