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

Device Problem Product Quality Problem (1506)

Patient Problems Burning Sensation (2146); Halo (2227)

Event Type  malfunction  

Manufacturer Narrative

The event described could be associated with application of unneutralized hydrogen peroxide coming in contact with the eye.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.¿ although repeated attempts to obtain additional information from the consumer were unsuccessful, the symptoms of burning and halos around lights are compatible with the toxnet description of a temporary condition associated with hydrogen peroxide exposure.The complaint sample was not returned for evaluation and its lot number was not provided.

Event Description

A consumer reported experiencing a burning sensation after using the product and inserting her lenses.The consumer also indicated that after removal of the lenses she experienced halos around lights.Additional information has been requested but has not been received.There was no report of a medical evaluation or medical treatment associated with the experience.The complaint suggests the device may have malfunctioned as a result of variability of neutralization.

• 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: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 6823545
• MDR Text Key: 83810151
• Report Number: 0001313525-2017-02738
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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
• Date Manufacturer Received: 07/30/2017
• 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: N
• Removal/Correction Number: Z-0651-2017
• Patient Sequence Number: 1