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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Keratitis (1944)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has been 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).
 
Event Description
As initially reported by the distributor on (b)(6) 2018 via personal communication, a male consumer had experienced irritation after contact lens wear. He sought medical attention on (b)(6) 2018 and was diagnosed with an unspecified corneal ulcer and keratitis. The consumer was prescribed with tobramycin eye drops and erythromycin ophthalmic ointment with an unknown dose and frequency. He visited his eye care specialist again last (b)(6) 2018 and confirmed that the symptoms did not subside. The consumer's eye status was unknown. Laboratory tests and further medical visits were not disclosed. As of (b)(6) 2018, the ecp confirmed that the symptoms were alleviating. As of (b)(6) 2018, additional information was received which had confirmed that on (b)(6) 2018 the consumer experienced keratitis in the right eye only located at 11 o'clock which was treated with ofloxacin ophthalmic solution with an unknown dose and frequency. It was also indicated that the consumer was diagnosed with corneal ulcer in the left eye only located at 11 o'clock with a visual acuity of 1. 2 or almost equal to 20/16. 6 after (b)(6) 2018. He was given ofloxacin and tobramycin antibacterial eye drops which was both applied eight times per day and erythromycin antibiotic eye ointment which was applied three times a day to treat the ulcer. It was also specified that the consumer¿s eye status had improved as of (b)(6) 2018. Further information cannot be obtained as consumer refused to provide more details.
 
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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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8170985
MDR Text Key130619149
Report Number3006186389-2018-00047
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 distributor,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberCBV92003420
Device Lot Number10319722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2016
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: 12/17/2018 Patient Sequence Number: 1
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