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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Corneal Ulcer (1796)
Event Type  Injury  
Event Description
A doctor reported that a consumer experienced corneal ulcer after wearing contact lenses. 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.
 
Manufacturer Narrative
The lot number was not provided and the complaint sample was not made available for evaluation. A dhr of the production information of the investigated lot could not be conducted. A relationship between the device and the reported incident or adverse event could not be established at this time. A root cause related to our product could not be determined. The manufacturer internal reference number is: (b)(4).
 
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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
8175514979
MDR Report Key12932868
MDR Text Key281735481
Report Number9610813-2021-00018
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
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 Received11/09/2021
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: 12/06/2021 Patient Sequence Number: 1
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