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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 Eye Injury (1845); Ulcer (2274); Discomfort (2330)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not returned for evaluation; the lot number is unknown. 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 initially reported via telephone on (b)(6) 2018, a female consumer experienced a lot of discomfort after four hours of initial use which made her decide to seek medical help and visited the hospital. It was then made known that a wound on her eye and an unspecified ulcer on the other eye was seen upon examination. Medical treatment, laboratory tests and current eye condition was not disclosed. As of 26feb2018, additional details are being requested but not yet received. Further details received on 27feb2018 confirming that the suspected products were discarded and is unavailable for return. Additional data has been requested for samples of the same lot. Additional data was received on 05mar2018. The optician sent an email on (b)(6) 2018 confirming that the consumer is getting better. Medical records and other important details shall be sent within the week. As of 15mar2018, follow-up attempts were unsuccessful confirming that the consumer is unwilling and unable to follow up. Further data such as patient resolution and sample availability were unavailable.
 
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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 Key7365124
MDR Text Key103286862
Report Number3006186389-2018-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K133176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberCBV92027782
Device Lot Number10309096
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 Received06/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2016
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: 03/23/2018 Patient Sequence Number: 1
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