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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92000509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Red Eye(s) (2038); Ulcer (2274)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided and the complaint sample was not made available for evaluation. Manufacturing site inspected the retain samples of lot: 31350569 to ensure no possibility of product contamination. The retain samples inspection was performed by visual inspection for package integrity and vacuum testing to ensure no leakage or package integrity defect that could lead to contaminate product. The retain samples showed to meet specifications, no leakage and package integrity defect found. Based on the investigation, this lot has passed through all manufacturing process as required by the procedures. The lot was confirmed to meet all in-process and finished product specifications at the time of release. No root cause can be determined. The manufacturer internal reference number is: (b)(4).
 
Event Description
It was reported on (b)(6) 2019, that the consumer experienced irritation upon use of the complaint contact lens which prompted the consumer to seek the assistance of an eye care professional. On the same day, the consumer was examined by an ecp (examination done was not specified) and the results indicated that there was a small micro-ulcer noted at a 12 o¿clock position. The diagnosis given by the ecp was ¿be (both eyes) contact lens associated red eyes¿. No medication was prescribed for the right eye. Consumer was advised to avoid contact lens wear for the next seven days and to return for follow up in seven days as well. Additional information has been requested but not yet received.
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer (Section G)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8447262
MDR Text Key139669202
Report Number9681121-2019-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K033919
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
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberCBV92000509
Device Lot Number31350569
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 Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2018
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: 03/25/2019 Patient Sequence Number: 0
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