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U.S. Department of Health and Human Services

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

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 10326277
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Pain (1994); Red Eye(s) (2038); Discomfort (2330)
Event Date 04/01/2017
Event Type  Injury  
Manufacturer Narrative
The previously reported contact lens number 10326277 was not confirmed to be part of the complaint and is not considered a suspect product in the reportable event previously submitted on rbad. Please reference manufacturer report number 3006186389-2017-00078 for information regarding the reportable event that occurred.
 
Event Description
Initial report: as initially reported by an eye care professional, a patient experienced discomfort and foreign body sensation associated with the wearing of a contact lens for which a surface defect was seen. Further information received via completed adverse event questionnaire stated that patient experienced "grain of sand" sensation, irritation, and pain in her right eye immediately upon wearing of the contact lens; severe eye redness was also reported. The patient was diagnosed with a corneal ulcer. Correction: initially, it was reported that the event resolved with no sequela and that the patient has resumed contact lens wear.
 
Manufacturer Narrative
This is the first of two reports for the same patient involving two lot numbers of the same product. It is unknown which contributed to the event. Another report will be filed under manufacturer internal reference number (b)(4) for a description of the other reported lot number. 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
As initially reported by an eye care professional, a patient experienced discomfort and foreign body sensation associated with the wearing of a contact lens for which a surface defect was seen. Further information received via completed adverse event questionnaire stated that patient experienced "grain of sand" sensation, irritation, and pain in her right eye immediately upon wearing of the contact lens; severe eye redness was also reported. The patient was diagnosed with a corneal ulcer.
 
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Brand NameAIR OPTIX AQUA
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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6847392
MDR Text Key112592879
Report Number3006186389-2017-00077
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Lot Number10326277
Other Device ID Number000000000010042526-155673400
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 Received09/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/06/2017 Patient Sequence Number: 1
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