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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
Lot Number ASKU
Device Problem Insufficient Information (3190)
Patient Problems Irritation (1941); Ulcer (2274)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided and the complaint sample was not made available for evaluation. The manufacturing review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
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 on (b)(6) 2017 by the consumer via website, the consumer was seen by a doctor on (b)(6) 2016 due to irritation and was diagnosed with a 'scratch'. On (b)(6) 2016 the consumer went back to his doctor and found out that it has developed into an 'ulcer'. It was reported that it took a while to resolved the event and he was not able to wear contact lenses until his annual eye exam on (b)(6) 2016. At the time of report, the treatment was unspecified and the consumer's eye status has resolved. Additional information was 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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6871514
MDR Text Key247293581
Report Number9681121-2017-00069
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
Other Device ID NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
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?
Type of Device Usage

Patient Treatment Data
Date Received: 09/18/2017 Patient Sequence Number: 1
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