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

Device Problem Product Quality Problem (1506)

Patient Problem Increased Sensitivity (2065)

Event Date 05/31/2016

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 consistent with the toxnet description of a temporary condition associated with hydrogen peroxide exposure.The complaint sample was not returned for evaluation.While the lot number was not provided, the consumer did provide the product¿s associated expiration date and did confirm that she had been using expired product.Note that this event is being retrospectively reported to fda due to the result of a remediation activity.

Event Description

Consumer reported that after using the product she developed a sensitivity to light in both eyes for which she consulted a doctor.The doctor was reported to have diagnosed photophobia and was reported to have provided an unidentified treatment.Ten days after initial contact with consumer, consumer indicated that she discovered that the product being used was expired and speculated that was the cause of the transient symptoms.At this point, consumer also corrected her earlier report and indicated that treatment was not required.Consumer is recovered.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: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 6428849
• MDR Text Key: 70760510
• Report Number: 0001313525-2017-02240
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• 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 Number: Z-0651-2017
• Patient Sequence Number: 1