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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 CBVUNK00007
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Red Eye(s) (2038); Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
This is the second of the two reports for the same patient involving two lot numbers of the same product. Refer to (b)(4) for the reported unknown lot number of the power -500. 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 from the office of the eye care provider (ecp) on (b)(6) 2018, via telephone, that a female patient experienced eye redness. The patient stated that her eye had an ulcer at one occasion, but still wanted to continue lens wear. Additional information was received on the same day from the patient and confirmed that she experienced eye redness, which was later on developed into corneal ulcer. Medical attention was sought; treatment was unknown. The patient reported that the ulcer and eye redness had resolved, but occasionally was experiencing irritation. This event happened to both of her eyes. No further information can be obtained.
 
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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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key8153626
MDR Text Key130115515
Report Number3006186389-2018-00046
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K133176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00007
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1
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