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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. IOL WEB-BASED CALCULATOR, ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC LENS, INTRAOCULAR, TORIC OPTICS

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ALCON LABORATORIES, INC. IOL WEB-BASED CALCULATOR, ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number VER. 1.3.2
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Type  Injury  
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. Results from the product history record review indicated the product met release criteria. (b)(4).
 
Event Description
A surgeon reported an unspecified adverse event. Additional information was provided by a facility representative that the reading from the previous online intraocular lens (iol) calculator was used for the initial iol implantation and upon post-operative evaluation, using the current online iol calculator, a different iol was indicated. An iol exchange was performed.
 
Manufacturer Narrative
The root cause cannot be determined based on the information provided. The manufacturer internal reference number is: (b)(4).
 
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Brand NameIOL WEB-BASED CALCULATOR, ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON LABORATORIES, INC.
6201 south freeway
fort worth TX 76134
Manufacturer (Section G)
ALCON LABORATORIES, INC.
6201 south freeway
fort worth TX 76134
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7607029
MDR Text Key111239314
Report Number1610287-2018-00021
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberVER. 1.3.2
Device Catalogue NumberALCUNK00005
Device Lot NumberASKU
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 Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/15/2018 Patient Sequence Number: 1
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