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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number ASKU
Device Problem Material Deformation (2976)
Patient Problem Corneal Ulcer (1796)
Event Date 12/28/2016
Event Type  Injury  
Manufacturer Narrative
This is the second of two reports for the same patient, as product was received for evaluation from both complaint lot number 10274470 and an unknown complaint lot. This report represents the unknown complaint lot received; please see additional report submitted under manufacturer internal reference number (b)(4). For a description of complaint lot 10274470. 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
As reported by an optician on (b)(6) 2016, a consumer experienced a corneal ulcer due to deformed contact lenses. The event was reported as resolved. Additional information has been requested, but has not been received.
 
Manufacturer Narrative
This is the second of two reports for the same patient, as product was received for evaluation from both complaint lot number 10274470 and an unknown complaint lot. This report represents the unknown complaint lot received; please see additional report submitted under manufacturer internal reference number (b)(4) for a description of complaint lot 10274470. The manufacturing review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined. The manufacturer internal reference number is: (b)(4).
 
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Brand NameAIR OPTIX AQUA MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer (Section G)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer Contact
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6284912
MDR Text Key66005894
Report Number3006186389-2017-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
Other Device ID NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2017 Patient Sequence Number: 1
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