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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 Problem Cellulitis (1768)
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 company representative reported on behalf of a healthcare provider that a consumer using contact lenses for a number of years, could not remove the lens from the eye and continued to wear the lens for a month. The customer did not reach the healthcare provider's office to discuss the issue, and subsequently, developed cellulitis and was hospitalized. It is unknown at this time in which eye the reported issue occurred. Additional information has been requested for this event, however, it has not yet been 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 Key14111214
MDR Text Key289258113
Report Number9610813-2022-00006
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 Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
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
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: 04/14/2022 Patient Sequence Number: 1
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