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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ULTRA FOR PRESBYOPIA CONTACTLENS LENSES, SOFT CONTACT, DAILY WEAR

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BAUSCH & LOMB INCORPORATED ULTRA FOR PRESBYOPIA CONTACTLENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 222
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Neovascularization (1978); Blurred Vision (2137); Visual Impairment (2138); Eye Infections (4466); Eye Pain (4467)
Event Date 10/12/2021
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested from the consumer, but not received. Device has been discarded and a device history record review is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
A consumer reported that they wore their contact lens continuously for 6-7 days. After a week, the consumer removed and disinfected the contact lens. Their left eye because red, itchy, painful, and they reported they were not able to see out of it. They went to the doctor two days later and was diagnosed with an infected corneal ulcer. The consumer was treated with tobramycin-13. 6mg and vancromycin-24mg every hour for 28 hours and to return to the office in two days. The doctor indicated they should not be wearing lenses continuously. The consumer reports some of their vision has returned, but not fully and they are still being treated with steroids. Additional information has been requested but not received.
 
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Brand NameULTRA FOR PRESBYOPIA CONTACTLENS
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 INCORPORATED
1400 north goodman street
rochester NY 14609
Manufacturer Contact
jennifer gamet
1400 north goodman street
rochester, NY 14609
MDR Report Key13238033
MDR Text Key283691000
Report Number0001313525-2022-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
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
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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