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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU FRESH MULTI-PURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS
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BAUSCH & LOMB INCORPORATED RENU FRESH MULTI-PURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Keratitis (1944)
Event Date 02/29/2020
Event Type  Injury  
Manufacturer Narrative
Product availability is currently unknown.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
 
Event Description
A patient reported experiencing irritation in the left eye after using contact lens solution.The patient was seen by a doctor two days after experiencing symptoms and was diagnosed with a bacterial infection and corneal ulcer.The patient was prescribed vigamox, hydrogel, doxycycline, lacrifilm, regencel, and dipyrone.The patient was also told to suspend contact lens wear.The patient has recovered from the bacterial infection and corneal ulcer, however the patient is now experiencing blurred vision, light sensitivity and discomfort.
 
Manufacturer Narrative
The complaint sample has been discarded.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
 
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Brand Name
RENU FRESH MULTI-PURPOSE SOLUTION
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
1400 north goodman street
rochester NY 14609
MDR Report Key9921979
MDR Text Key187256168
Report Number0001313525-2020-00067
Device Sequence Number1
Product Code LPN
Combination Product (y/n)Y
PMA/PMN Number
K020802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 01/01/2005,03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received05/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SOFLENS59
Patient Outcome(s) Required Intervention;
Patient Age25 YR
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