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U.S. Department of Health and Human Services

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

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PT. CIBA VISION BATAM FRESHLOOK COLORBLENDS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92002351
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930)
Event Date 01/12/2019
Event Type  Injury  
Manufacturer Narrative
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
It was initially reported on (b)(6) 2019 regarding a consumer who suffered from an eye infection. Further information was received on (b)(6) 2019 from the consumer via email inclusive of responses to follow up questionnaire. It was noted that the event occurred on (b)(6) 2019 with a reported condition of eye infection in consumer's left eye (os). The consumer sought for medical attention and was diagnosed with corneal ulcer in os with unresolved symptoms. The prescribed medication was ofloxacin eye drops which was administered every hour. On (b)(6) 2019, additional information was received from the consumer with a confirmed symptoms resolution after using the prescribed medication. Additional information has been requested but not yet received.
 
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Brand NameFRESHLOOK COLORBLENDS
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 Key8349432
MDR Text Key136481666
Report Number9681121-2019-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181796
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92002351
Device Lot Number31334795
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/08/2018
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: 02/19/2019 Patient Sequence Number: 1
Treatment
OFLOXACIN
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