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U.S. Department of Health and Human Services

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

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX COLORS; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00007
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)
Event Type  Injury  
Manufacturer Narrative
This is the first of the two reports for the same patient involving two lot numbers of the same product.Refer to (b)(4) for the reported unknown lot number of the power -450.The complaint sample has not returned for evaluation; the lot number is unknown.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 from the office of the eye care provider (ecp) on (b)(6) 2018 via telephone, that a female patient experienced eye redness.The patient stated that her eye had an ulcer at one occasion but still wanted to continue lens wear.Additional information was received on the same day from the patient and confirmed that she experienced eye redness which was later on developed into corneal ulcer.Medical attention was sought; treatment was unknown.The patient reported that the ulcer and eye redness had resolved but occasionally was experiencing irritation.This event happened to both of her eyes.No further information can be obtained.
 
Manufacturer Narrative
This is the first of the two reports for the same patient involving two lot numbers of the same product.Refer to 2018-86194-01 for the reported unknown lot number of the power -450.Device evaluated by mfr the lot number was not provided and the complaint sample was not made available for evaluation.The trend investigation has been completed and there was no any unfavorable trend identified for the entire event related to this complaint for the past 24 months.No any significant of signal or pattern identified in the trend during this review period.The root cause could not be determined.The manufacturer internal reference number is: 2018-86194.
 
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Brand Name
AIR OPTIX COLORS
Type of Device
LENSES, 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
MDR Report Key8148842
MDR Text Key129880390
Report Number3006186389-2018-00045
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K133176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberCBVUNK00007
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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