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

Lot Number GL15048

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Inflammation (1932); Rash (2033); Reaction (2414)

Event Date 02/13/2016

Event Type  malfunction  

Manufacturer Narrative

The symptoms reported are consistent with contact urticaria, "an immediate but transient localized swelling and redness that occurs on the skin after direct contact with an offending substance (source: dermnet new zealand - contact urticaria).The u.S.National library of medicine toxicology data network (toxnet) reports that hydrogen peroxide can be an irritant to the skin with paraesthesia, blistering and whitening.The symptoms reported may be consistent with a temporary condition associated with hydrogen peroxide exposure.The complaint sample was returned for evaluation and the results of the chemical testing performed were consistent with shelf life limits.Note that this event is being retrospectively reported to fda due to the result of a remediation activity.

Event Description

A consumer reported experiencing an allergic reaction on his eyelids following initial use of the product.Consumer visited urgent care center.Information obtained from this center indicates patient presented with erythema, inflammation and a skin rash around both eyes.Patient was prescribed a steroid.Consumer also reported using hydrocortisone cream around his eyes.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: 6410974
• MDR Text Key: 70131051
• Report Number: 0001313525-2017-01792
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 00310119038161
• UDI-Public: 310119038161
• 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,health professional
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/18/2016

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
• Device Expiration Date: 05/31/2017
• Device Lot Number: GL15048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0651-2017
• Patient Sequence Number: 1
• Patient Age: 28 YR