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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM O2 OPTIX LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM O2 OPTIX LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Foreign Body Sensation in Eye (1869); Ulcer (2274)
Event Date 01/05/2021
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: 2021-01717.
 
Event Description
As initially reported by an female consumer via telephone on 07jan2021, it was reported that on 05jan2021, consumer used a new pair of lenses, after few hours of usage, she experienced foreign body sensation and stinging and developed redness after lens removal. The consumer went to the hospital and was told that there were plenty of ulcers in the eye. The consumer was treated with unspecified needle injection through her eye. Symptoms were resolved. Additional info has been requested but not yet available.
 
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Brand NameO2 OPTIX
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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key11199930
MDR Text Key227720147
Report Number9681121-2021-00002
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00001
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 Received02/01/2021
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: 01/20/2021 Patient Sequence Number: 1
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