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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION GMBH PRECISION1 LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION GMBH PRECISION1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00155
Device Problem Difficult to Remove (1528)
Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869)
Event Date 03/01/2022
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. The manufacturer internal reference number is: (b)(4).
 
Event Description
A consumer reported that she experienced discomfort after few hours of wearing the contact lenses and had great difficulty in removing them. Consumer also experienced ulcer in eye. The current status of the consumer's eye is not known at the time of this report. Additional information has been requested but not yet received.
 
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Brand NamePRECISION1
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
8007579780
MDR Report Key13994551
MDR Text Key288480945
Report Number9610813-2022-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K182902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00155
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2022 Patient Sequence Number: 1
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