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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 CBV92001360
Device Problem Break (1069)
Patient Problem Ulcer (2274)
Event Date 06/01/2018
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 was initially reported by an optician on 07aug2018 regarding a patient who had broken contact lenses inside the eyes for several times. On 10aug2018, further information was received via telephone from the optician and stated that the patient has experienced broken contact lenses twice. It was reported that the last incident had made the patient go to emergency room for treatment and he was diagnosed with 'ulcer in the right eye (od)' and 'inferior punctate. ' it was also stated that the patient was prescribed with unknown antibiotic and with unknown treatment modality. At the time of the report, the patient's current eye status is unknown. Additional information was received on 23aug2018 from the optician confirming that the event happened around end of (b)(6) 2018 to beginning of (b)(6) 2018. There was no report on symptoms resolution. 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 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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7841639
MDR Text Key119035175
Report Number1065835-2018-00014
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
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,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberCBV92001360
Device Lot NumberN0635780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2015
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: 09/04/2018 Patient Sequence Number: 1
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