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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS MULTIFOCAL LENS, CONTACT, (DISPOSABLE)

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CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS MULTIFOCAL LENS, CONTACT, (DISPOSABLE) Back to Search Results
Catalog Number CBV92037195
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not been 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. The manufacturer internal reference number is: (b)(4).
 
Event Description
It was reported by an optician on (b)(6) 2018 that the consumer felt discomfort and burning sensation upon introduction of contact lens samples to the right eye. The consumer continued with the contact lenses in the eye until the end of the day. The pain sensation did not resolve, so the consumer went to the ophthalmologist who identified a "lesion in the eye like a burning". Contact lens usage was suspended for 15 days. At the time of the initial report, symptom resolution is unknown. Additional information has been requested but not yet received.
 
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Brand NameDAILIES AQUACOMFORT PLUS MULTIFOCAL
Type of DeviceLENS, CONTACT, (DISPOSABLE)
Manufacturer (Section D)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8226303
MDR Text Key132372523
Report Number1065835-2019-00001
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K123994
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
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92037195
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/08/2019 Patient Sequence Number: 1
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