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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 Device Expiration Issue (1216)
Patient Problem Corneal Ulcer (1796)
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
As initially reported by an eye care provider (ecp), a patient presented corneal ulcers at the 10-11 o'clock located peripherally on the left eye. The patient reportedly used lenses that were expired last year. Additional information was received on 05/17/2017, via telephone, from the ecp that the patient's symptoms were improving and that the patient was scheduled to be refitted with contact lenses. 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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6609939
MDR Text Key76589624
Report Number1065835-2017-00016
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
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 Received05/11/2017
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
Removal/Correction NumberNOT APPLICABLE

Patient Treatment Data
Date Received: 06/02/2017 Patient Sequence Number: 1
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