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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 R62003573
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Irritation (1941); Swelling (2091); Blurred Vision (2137)
Event Date 10/22/2018
Event Type  Injury  
Manufacturer Narrative
The consumer has discarded the lens. They provided two possible lot numbers for the complaint lens. A review of the lot 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
Consumer reported that they inserted a new lens on (b)(6) 2018 and wore it continuously until (b)(6) while spending those days on a boat in the ocean. They began to develop irritation in the left eye. Upon visiting a doctor cultures were performed and the results revealed an infection that one can obtain from a ''cow udder''. The consumer reports they initially visited the retail location that fit them into the lenses. The retail location did not examine, diagnose, or treat the consumer. Instead they referred the consumer to an ophthalmologist. The patient was seen by the ophthalmologist on (b)(6) 2018. Information obtained from the ophthalmologist¿s office indicated that the patient had taken a 2-3 week contact lens holiday. When the patient resumed lens wear they experienced irritation, blurry vision and swelling in the left eye. The patient was diagnosed with left eye corneal ulcer and was referred to a corneal specialist the following day. No treatment was provided by ophthalmologist. Information obtained from the corneal specialist¿s office indicated that the patient was seen on (b)(6) with left eye irritation, blurred vision and a corneal ulcer ¿ which they had been experiencing for two days. A culture was taken on this day and the results indicated streptococcus dysgalactiae. The patient was prescribed vancomycin and ofloxacin eye drops to be used every hour while awake and every three hours while asleep. As the patient recovered, they were instructed to taper use of the eye drops. As of (b)(6) 2018 the patient had recovered with no loss of vision. However, a central stromal scar remains. According to the corneal specialist, the patient is not compliant with contact lens wear and does not obey prescribed wear times. The corneal specialist attributes the event to the patient¿s non-compliance with proper contact lens wear, not the contact lens itself.
 
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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 Contact
jennifer gamet
1400 north goodman street
rochester, NY 14609
5853386853
MDR Report Key8232125
MDR Text Key132567451
Report Number0001313525-2019-00007
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
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 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/15/2019
Device Lot NumberR62003573
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2016
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: 01/09/2019 Patient Sequence Number: 1
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