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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
Catalog Number CBV92037121
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Occlusion (1984); Pain (1994); Discomfort (2330)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
The complaint product was returned for evaluation and was found to meet manufacturing specifications. 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).
 
Event Description
It was reported that a consumer experienced corneal ulcer from the use of the complaint contact lenses. Additional information was received on 10aug2019 via email. It was reported that the consumer experienced difficulty on putting on the contact lenses in the left eye (os) as well as strong irritation on the eye. The problem occurred with more than 20 contact lenses and removal of the contact lenses resolved the issues. The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal ulcers. The consumer was treated with unspecified occlusion, epithelialization and anesthetic. Additional information was received on 14aug2019. It was reported that there was no data for the location of the corneal ulcer. The consumer felt pain which was difficult to describe and the consumer had difficulty opening both eyes. The consumer felt relief after the eye care professional (ecp) applied unspecified drops and a cream. The ecp noted that the eye scarred well after the treatment and revision. Additional information regarding the event was requested from the ecp. On 25jun2020, additional product with a different lot number was received from the ecp. Follow-up with the ecp was unsuccessful in determining the association of the newly reported lot to the event as reported above. No further information is available.
 
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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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10326638
MDR Text Key208329970
Report Number9610813-2020-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92037121
Device Lot NumberN1171733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/27/2020 Patient Sequence Number: 1
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