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U.S. Department of Health and Human Services

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

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX COLORS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92027782
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Irritation (1941); Ulcer (2274)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not returned for evaluation. 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. (b)(4).
 
Event Description
It was reported via a telephone call by a female consumer that she experienced irritation and her eyes felt heavy. She added that she got an unrelated eye infection which turned into an ulcer on her right eye (od). It was noted that symptoms had resolved and she was able to wear contact lenses. Additional information has been requested but not yet received.
 
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Brand NameAIR OPTIX COLORS
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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7825824
MDR Text Key118527661
Report Number3006186389-2018-00028
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberCBV92027782
Device Lot Number10369056
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 Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2017
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: 08/29/2018 Patient Sequence Number: 1
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