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

Lot Number GJ14142

Device Problem Product Quality Problem (1506)

Patient Problems Conjunctivitis (1784); Pain (1994); Red Eye(s) (2038); Visual Disturbances (2140); Burning Sensation (2146); Excessive Tear Production (2235); Discomfort (2330)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

The event described is consistent with application of unneutralized hydrogen peroxide coming in contact with the eye.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.The event may also be associated with use of expired product.The complaint sample was not returned.

Event Description

Consumer reported experiencing a burning sensation in her left eye upon initial use of product.The consumer indicated that she read the instructions and followed them completely.It should be noted, however, that the expiration date the consumer provided (31-aug-2017) was inconsistent with the actual expiration date (31-mar-2016) associated with the provided product lot number.Consumer reported visiting an emergency department relative to this event.Consumer stated that she was diagnosed with conjunctivitis and prescribed erythromycin ophthalmic ointment to be used for seven days in the left eye only.Consumer indicated that she missed three days of work as a consequence of this experience.Consumer reported that she is no longer experiencing any pain but that vision in her left eye is still poor.Consumer did not seek any follow-up care.Additional information has been requested but has not been received.The complaint suggests the device may have malfunctioned as a result of variability of neutralization.The event may also be associated with use of expired product.

Manufacturer Narrative

The complaint sample was returned but was not evaluated as testing of expired product cannot be reliably used to determine a root cause for the reported event.

Event Description

Follow-up information obtained from the consumer indicates that there are occasional mornings on which she still experiences poor vision in her left eye.Consequently, consumer has now missed additional days of work.Additional information has been requested but has not been received.

Manufacturer Narrative

The symptoms and signs reported are consistent with the toxnet description of a temporary condition associated with hydrogen peroxide exposure.Consumer originally reported visiting emergency department on (b)(6) 2017.Medical records obtained from the emergency department indicate that she was actually seen on (b)(6) 2017.

Event Description

Medical records dated (b)(6) 2017 were received from the emergency department visited by the consumer.The history of patient illness indicated that the patient was experiencing pain, redness and tearing that resulted from putting a certain kind of contact lens solution in her left eye.The patient reported symptoms of burning and stinging when the lens was placed on the left eye.The pain was reported as moderate and continuous.With lens removal, the pain did not improve.The report on the ocular examination indicated that the periorbital structures appeared normal.Pupils were equal, round and reactive to light and accommodation.Extraocular movements were intact throughout.Conjunctiva was injected in the left eye and tearing was noted.Corneas were normal with no evidence of abrasion and no foreign body.Lids and lashes appeared normal.The diagnosis was conjunctivitis - chemical.The patient was prescribed anaprox ds (oral pain medication) and erythromycin ophthalmic ointment (antibiotic).

• 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: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 6970998
• MDR Text Key: 90795812
• Report Number: 0001313525-2017-02819
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 00310119038161
• UDI-Public: 310119038161
• Combination Product (y/n): Y
• 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,Followup,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Lot Number: GJ14142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2014
• 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: 42 YR