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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION GMBH DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number ASKU
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
Single use device from no to yes. 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
It is initially reported by an optician on 03/31/2017 that after being introduced to the complaint product, a patient returned twelve days later with an unspecified ulcer. The optician recommended that the consumer consult an eye care professional. Additional information was received via email on 04/14/2017. 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 upper temporal corner of the eye was affected. At the time of this report, the patient was no longer wearing lenses due to eye dryness. Additional information has been requested but not yet received.
 
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Brand NameDAILIES TOTAL 1 MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer (Section G)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6516489
MDR Text Key270555678
Report Number9610813-2017-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K113168
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 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot 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 Received02/09/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2017 Patient Sequence Number: 1
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