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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 Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)
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 initially reported by a distributor via email on (b)(6) 2018 that a female consumer had an eye infection in her left eye after wearing the contact lenses. She threw away the lenses she was wearing, the case and solution. After the infection cleared up, she wore the lenses and got another eye infection in her left eye. Her ecp diagnosed a corneal ulcer of the left eye. New information obtained from the consumer via phone follow-up on 30mar2018 stated that she did not remember the exact date of event. Upon putting the first contact lens in her left eye, she experienced redness and irritation within an hour of wear. The consumer removed the contact lens and went to see her ecp who informed her that she had a bacterial infection which was a result of wearing the contact lens. She threw out the contact lens and wore glasses until her symptoms resolved. At that point, she tried to wear another contact lens for the left eye from the same box and within hours experienced redness and irritation. She removed the contact lens and went again to see her ecp who diagnosed her with corneal ulcer. The consumer was prescribed besifloxacin %0. 6 with an unspecified treatment modality. Her symptoms have completely resolved and she was wearing glasses. 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 Key7436568
MDR Text Key105716946
Report Number3006186389-2018-00013
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
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 Number10309654
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2016
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: 04/17/2018 Patient Sequence Number: 1
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