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U.S. Department of Health and Human Services

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

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CIBA VISION GMBH DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001362
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulcer (2274)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturer report number corrected and reported under mfg report num. 9610813-2018-00003, mfg site registration 9610813. The manufacturer internal reference number is: (b)(4).
 
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 reported by an optical shop, a consumer contacted them to report that she developed an ulcer in (b)(6) 2017, for which her eye care professional (ecp) attributed to contact lens wear. The consumer expressed concern regarding the quality of the affected lot number. It was reported that the event resolved. Additional information has been requested but not yet received.
 
Manufacturer Narrative
The complaint product was returned for evaluation and was found to meet manufacturing specifications. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. 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. The manufacturer internal reference number is: (b)(4).
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt GA D-638 68
GM D-63868
Manufacturer (Section G)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt GA D-638 68
GM D-63868
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6454574
MDR Text Key195838045
Report Number1065835-2017-00007
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Catalogue NumberCBV92001362
Device Lot NumberN0641756
Other Device ID Number000000000010039334-155671300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2016
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: 04/03/2017 Patient Sequence Number: 1
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