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

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Reaction (2414)

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 is consistent 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

A representative from a competitive eye care company sent an email reporting that they had a consumer who, during an inquiry about the competitor¿s product, indicated that they were unable to use peroxiclear due to an allergic reaction.Since the consumer did not provide consent to be contacted by bausch + lomb, the representative only provided the consumer''s initials: g.B.Follow-up for additional information was not possible.

• 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: 6424376
• MDR Text Key: 70561468
• Report Number: 0001313525-2017-02107
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• 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: N
• Removal/Correction Number: Z-0651-2017
• Patient Sequence Number: 1