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U.S. Department of Health and Human Services

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

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CIBA VISION GMBH DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00077
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Keratitis (1944); Ulcer (2274)
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 on (b)(46 2018 by a consumer via website that the contact lens has caused an ulcer on unspecified eye site. The consumer has her affected eye covered for four days together with unspecified eye drops and wearing of sunglasses as a treatment. It was also reported that the consumer has been using contact lenses for years without any problem but did not expect that with disposable daily contact lens will caused her damage. At the time of the report, the consumer's eye status is unknown. Further information was received on (b)(6) 2018 from the consumer. The consumer reported that she visited an ophthalmologist who confirmed an infectious ulcer in her eye which was caused by keratitis. She also mentioned that it could be due to her pre-existing dry eye. As a treatment, the consumer was prescribed with an unspecified antibiotic and moisturizing solution with unspecified treatment modality and to be continued even after the event's resolution. It was also reported that the consumer has resumed to contact lens wear. The consumer also added that the event may not be related to contact lens used as it was caused by her pre-existing condition. She also expressed her dissatisfaction with the product used. At the time of the report, the consumer's eye status has resolved. As per information added on 07sep2018, the consumer's injury was due to her pre-existing dry eye and thought the contact lens was not related to the event. Thus, no additional information can be obtained from the consumer.
 
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Brand NameDAILIES TOTAL 1
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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7897394
MDR Text Key120989901
Report Number9610813-2018-00023
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 consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00077
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/21/2018 Patient Sequence Number: 1
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