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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION CORPORATION UNKNOWN CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00090
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cataract, Induced (1767); Corneal Ulcer (1796); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not returned for evaluation; the lot number is unknown. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by a consumer via email on 11oct2020, consumer stated that on an unknown date the consumer experienced ulceration caused by the lens ended with a scar in the middle of the cornea and an infection. Only 25% of the cornea are good and is just like cataracts. Symptoms outcome was resolved with herbal remedies which could not be cured by physician not even in the best recognized hospital. Additional info has been requested but not yet available.
 
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Brand NameUNKNOWN CONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION CORPORATION
333 e. howard avenue
des plaines IL 60018
Manufacturer (Section G)
CIBA VISION CORPORATION
333 e. howard avenue
des plaines IL 60018
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10705497
MDR Text Key212296045
Report Number9681121-2020-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00090
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 Received12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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