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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED PEROXICLEAR HYDROGEN PEROXIDE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

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BAUSCH & LOMB INCORPORATED PEROXICLEAR HYDROGEN PEROXIDE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problem Increased Sensitivity (2065)
Event Type  malfunction  
Manufacturer Narrative
The u.S.National library of medicine toxicology data network (toxnet) describes the scope of injury associated with hydrogen peroxide exposure to the ocular tissue, ¿hydrogen peroxide is irritating to the eyes with a burning sensation, conjunctival hyperemia, lacrimation and severe pain which resolves within a few hours.There are rare cases of temporary corneal injury resulting from the application of 3% solution to the eye on contact lenses including punctate staining of the cornea, decreased vision, corneal opacity and edema.¿ the symptom reported may be associated with the toxnet description of a temporary condition associated with hydrogen peroxide exposure.Note that this event is being retrospectively reported to fda due to the result of a remediation activity.
 
Event Description
Consumer reported that approximately ten days after initiating use of the solution, he began experiencing light sensitivity.Consumer reported that his doctor provided an over-the-counter artificial tear in response to the symptom.Contact information for the treating doctor was requested but was not provided.The complaint suggests the device may have malfunctioned as a result of variability of neutralization.
 
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Brand Name
PEROXICLEAR HYDROGEN PEROXIDE SOLUTION
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
1400 north goodman street
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB
8507 pelham road
greenville SC 29615
Manufacturer Contact
sharon spencer
50 technology drive west
irvine, CA 92618
9493985698
MDR Report Key6417669
MDR Text Key70369382
Report Number0001313525-2017-01990
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial
Report Date 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/16/2016
Initial Date FDA Received03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0651-2017
Patient Sequence Number1
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