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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 CBV92092165
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Ulcer (2274); Discomfort (2330)
Event Date 02/03/2021
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. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by a physician via personal communication on (b)(6) 2021, it was stated that on an unspecified date, consumer experienced discomfort after wearing the lens for 2 - 3 days of use, the consumer visited the physician and was diagnosed with ulcer. Symptoms were continuing. Additional info has been requested but not yet available.
 
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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 Key11320991
MDR Text Key231616815
Report Number9610813-2021-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K182902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92092165
Device Lot NumberN4008312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2020
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: 02/12/2021 Patient Sequence Number: 1
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