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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number ASKU
Device Problem Insufficient Information (3190)
Patient Problems Scarring (2061); Ulcer (2274)
Event Date 02/07/2017
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided and the complaint sample was not made available for evaluation. The manufacturing review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined. (b)(4).
 
Event Description
It is reported by an optician that, a patient, having worn this type of contact lenses for many years, was diagnosed with ulcer on (b)(6) 2017. No additional information is available at this time; additional information has been requested but not yet received. Additional information was received via email on 04/12/2017. The optician reported that only the left eye was affected and prescribed an unspecified medication; treatment modality and duration were not provided. It was also reported that the patient's left eye peripheral nasal had a scar. At the time of this report, the patient was not wearing lenses anymore. Additional information has been requested but not yet received.
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6521928
MDR Text Key73706205
Report Number1065835-2017-00010
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
Other Device ID NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
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

Patient Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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