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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

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BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Discomfort (2330)
Event Date 12/11/2020
Event Type  Injury  
Manufacturer Narrative
The retail location confirmed that product has been discarded. Sealed lenses were returned from the same complaint lot, they were evaluated and it was determined the lenses were in specification. A review of the device history records is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
A retail location reported that a patient inserted their contact lens and experienced discomfort and visited an eye clinic. Follow up with the retail location indicated that the patient visited the doctor and was diagnosed with a right eye infective corneal ulcer. The patient was prescribed gatiflo ophthalmic solution 6 times a day and to temporarily discontinue contact lens wear. The patient followed up with the doctor a week later and they had resumed lens wear and fully recovered. It was confirmed that cultures were not taken of the eye. Additional information was requested, but direct contact with the doctor was denied.
 
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Brand NameULTRA (SAMFILCON A) CONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
1400 north goodman street
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB
1400 north goodman street
rochester NY 14609
Manufacturer Contact
jennifer gamet
1400 north goodman street
rochester, NY 14609
5853386853
MDR Report Key11344032
MDR Text Key232408775
Report Number0001313525-2021-00021
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K131208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
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