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U.S. Department of Health and Human Services

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

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PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92000509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Excessive Tear Production (2235); Discomfort (2330)
Event Date 12/31/2020
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. This is the second of two reports for the same patient involving two lot numbers of the same product. It is unknown which contributed to the event. Refer to the first report filed under the manufacturer internal reference number of (b)(4) for the reported lot number 31380990. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by a health care professional, a consumer had been experiencing discomfort, red eye and tearing in the left eye (os) which resolved with removal of the contact lenses. The consumer visited the ophthalmologist and was diagnosed with a corneal ulcer in the os. The use of contact lenses was suspended for three months and consumer recovered from ulcer on (b)(6) 2021. The consumer resumed contact lens wear and experienced a new "lesion" in the os, which was treated with a combination of gatifloxacin 0. 3% one drop a day for fifteen days and dexamethasone 0. 1% for ten days. The current status of the consumer¿s eye is recovered. Additional information has been requested, but not yet received.
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
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 Key12553385
MDR Text Key273989270
Report Number9681121-2021-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUY
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,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92000509
Device Lot Number31393807
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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