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

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Infection (1930); Irritation (1941); Pain (1994); Blurred Vision (2137); Halo (2227)

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.¿ in large part, the events described are not consistent with application of unneutralized hydrogen peroxide coming in contact with the eye.The primary long-term events reported by the consumer are associated with the posterior chamber of the eye; whereas exposure to unneutralized hydrogen peroxide signs and symptoms are associated with the cornea and conjunctiva and are of short-term duration.The complaint sample was not returned for evaluation.

Event Description

Consumer reported that she started to have mild eye irritation with foggy/blurry vision after using the product and that she visited a practitioner to assess if the problem was with her contact lenses.The consumer indicated that they were not able to find contacts that weren''t blurring.The consumer also reported that she had a series of ocular events; a large floater in her left eye, "ongoing eye infection-like symptoms in both eyes" (no description of symptoms), and a sudden onset of halo vision in both eyes with "severe pain in the optic nerve" of the right eye.The consumer indicated that she will have an evaluation by a retina specialist.Additional event/medical information has been requested but has not been received.It is possible that the device associated with the event 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: 6634327
• MDR Text Key: 77440496
• Report Number: 0001313525-2017-02607
• 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,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• 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: 05/15/2017
• 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