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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92003420
Device Problem Product Quality Problem (1506)
Patient Problems Purulent Discharge (1812); Hypopyon (1913); Unspecified Infection (1930); Irritation (1941); Keratitis (1944); Loss of Vision (2139)
Event Date 12/28/2019
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. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by a female consumer via email on 29jan2021. Consumer stated that on (b)(6) 2019, she was no longer wearing contacts because she went blind because of the infection from the contacts. It was also reported that contacts had a lethal parasite and scratched her eye. She was diagnosed with pseudomonas and need a cornea transplant because of going blind in her right eye. Additional information was received on 03feb2021, from her daughter states that incident occurred on (b)(6) 2019, involved od only, additionally patient reports that she put in a new contact lens and immediately felt like there was something in her eye. She tried cleaning the lens and flushing her eye out but this did not help. By the end of the day she had to take the lens out and ended up throwing it away other lenses from the same box were also irritating, it was alsor reported that on saturday of that week she couldn't tell if it was daytime or nighttime as she couldn't see any light. She is already non-seeing in os. After a few days a large pus pocket over the pupil was observed and the patient was referred to cornea specialist. On an unspecified date injections and multiple cultures tests were performed which showed microbial keratitis secondary to pseudomonas aeruginosa and an associated hypopyon. The consumer was treated with combination of antibiotic, antifungal and steroidal eye drops and antiviral and analgesic medication orally. Symptoms were continuing. Additional info has been requested but not yet available.
 
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Brand NameAIR OPTIX AQUA MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer (Section G)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key11387162
MDR Text Key234637317
Report Number3006186389-2021-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92003420
Device Lot Number10405082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
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: 02/26/2021 Patient Sequence Number: 1
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