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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 CBV92000079
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Eye Infections (4466)
Event Date 11/26/2021
Event Type  Injury  
Event Description
An optician reported that a consumer experienced "infection, double ulceration of the cornea and red eyes" after wearing contact lenses. The current status of the consumer's eye is not known at the time of this report. Additional information and product sample have been requested but not yet received this is the second of two product reports associated with the same patient. It is unknown which product lot is associated with each respective eye.
 
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. The manufacturer internal reference number is: (b)(4).
 
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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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12953408
MDR Text Key281860879
Report Number9681121-2021-00006
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181796
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 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92000079
Device Lot Number31437606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2021 Patient Sequence Number: 1
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