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

Lot Number GG15023

Device Problem Product Quality Problem (1506)

Patient Problems Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146)

Event Date 03/05/2016

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 symptoms reported are 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

Consumer reported using the product as directed and experienced immediate burning when inserting lens in right eye.Eye became red.Consumer discarded lens.After approximately 3 hours consumer reports right eye is still burning, vision is blurred and feels like there is something in the eye.Consumer was seen by a doctor who diagnosed red eye.Doctor also indicated that the event was related to the product as the patient did not allow peroxide to neutralize completely.No intervention was required.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: 6420719
• MDR Text Key: 70459371
• Report Number: 0001313525-2017-02037
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Lot Number: GG15023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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
• Treatment: AIR OPTIX AQUA MULTIFOCAL LENSES BY ALCON.
• Patient Age: 47 YR