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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 Ulcer (2274)
Event Date 11/03/2020
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 healthcare professional via email on 13nov2020, it was reported that, several female patients developed ulcers. After switching to these contact lenses, a female patent developed second ulcer. Symptoms resolution is unknown. Additional information has been requested.
 
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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 Key10903241
MDR Text Key218221975
Report Number9610813-2020-00014
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,Followup
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
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
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/25/2020 Patient Sequence Number: 1
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