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U.S. Department of Health and Human Services

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

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00091
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Ulcer (2274)
Event Type  Injury  
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 by a healthcare professional via letter on (b)(6) 2020 and stated that in the past the patient had pain in left eye upon laying of lens as if it was scratching the eye. She visited an ophthalmologist on an unknown date and was diagnosed with an ulcer without abscess. She was prescribed with an unspecified antibiotic treatment. On an unknown date symptoms resolved. Additional information has been requested but not yet available.
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10959811
MDR Text Key219992372
Report Number3006186389-2020-00015
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00091
Device Lot NumberASKU
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 Received12/22/2020
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: 12/07/2020 Patient Sequence Number: 1
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