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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92012369
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Irritation (1941); Ulcer (2274)
Event Date 11/26/2020
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. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by a physician via personal communication on (b)(6) 2020, consumer stated that on (b)(6) 2020 the consumer felt irritation when wearing the lens, the consumer removed the lens and found it torn. The consumer visited a doctor on (b)(6) 2020. The consumer was diagnosed with ulcer. Eye-drops (type : antibiotic(tobracin),antibacterial(cravit, tarivid)) were prescribed. The doctor instructed the consumer to come again on (b)(6) 2020. Symptom has not been resolved. Additional info has been requested but not yet available.
 
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Brand NameAIR OPTIX NIGHT & DAY AQUA
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 Key10940974
MDR Text Key219360341
Report Number9681121-2020-00006
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92012369
Device Lot Number31417739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2019
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: 12/03/2020 Patient Sequence Number: 1
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