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U.S. Department of Health and Human Services

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

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92037094
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ulceration (2116); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
This is the second of two reports for the same consumer involving two lot numbers of the same product. It is unknown which contributed to the event. Refer to 2018-73844-01 for the reported first lot number 10364202. 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). The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by an eye care professional (ecp) through letter on (b)(6) 2018, the ecp states that the consumer has been a user of air optix night and day contact lenses for a span of time, however, the consumer acquired a package of six contact lenses of air optix hydraglyde for each eye last (b)(6) 2018. After a few days of using the first pair from the package, the consumer reportedly felt discomfort and decided to try another pair, however, the same symptom was experienced so a new pair of lenses was opened. Due to the continuing symptoms, the consumer consulted an eye care professional, it was then found out the cause of the discomfort was an ulceration. The consumer was prescribed with an unspecified treatment regimen by the ecp in which the consumer cordially adhered, and as per the ecp¿s approval, the consumer was again allowed to use contact lenses however the consumer felt the same discomfort upon wearing. Additional information has been requested but not yet received at this time.
 
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Brand NameAIR OPTIX PLUS HYDRAGLYDE
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 Key8002380
MDR Text Key124952186
Report Number3006186389-2018-00038
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
P010019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberCBV92037094
Device Lot Number10363290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2017
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: 10/24/2018 Patient Sequence Number: 1
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