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

Lot Number GE16013

Device Problem Product Quality Problem (1506)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Conjunctivitis (1784); Corneal Abrasion (1789); Corneal Edema (1791); Corneal Ulcer (1796); Inflammation (1932); Iritis (1940); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Caustic/Chemical Burns (2549)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

The complaint sample was not returned for evaluation and neither medical information nor records were available for review from the hospital/doctor seen in (b)(6).The treating doctor from the consumer¿s home state indicated the solution may have possibly contributed to the event.

Event Description

A consumer indicated that he was hospitalized for "chemical burns" after initial use of the product in (b)(6) 2016, while on vacation in (b)(6).Following the hospital event, the consumer indicated that he saw another doctor in (b)(6).The consumer then traveled back to their home state, (b)(6), where they visited a third doctor on two separate dates in (b)(6).The consumer also indicated that in (b)(6) they used another bottle of the solution and experienced the same issue.The consumer visited their home state doctor again in (b)(6) and then twice in (b)(6).An office representative for the home state doctor indicated the patient was seen with symptoms of left eye redness, pain, blurry vision and photophobia.The patient was reported to have a history of keratoconus and uses scleral lenses.The diagnosis for the left eye was reported to be ulcerative keratitis and iritis.The office representative indicated that the patient is following up with the office "as needed" and has since recovered.When asked about the likely cause of the event, the doctor stated it could have been caused by an atypical acanthamoeba.At this time, the doctor did not mention if the event could have been caused by the product.In further follow-up, the office representative indicated that the doctor stated the solution could possibly be a contributing factor to the event but that the doctor could not be certain given that the office did not see the patient until about a week after the incident.It was reported that several medications were prescribed including prednisolone ac 1.0%, erythromycin 0.5% ointment, colymyxine tmp eye drops, gatifloxacin.5% eye drops, and ibuprofen.No medical information or records were available for review from the hospital/doctor seen in (b)(6).

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.¿ there are select symptoms reported that are consistent with the toxnet description of a temporary condition associated with hydrogen peroxide exposure.Information obtained from treating doctor confirms patient inadvertently used product directly in the eye.This represents a user error; patient did not use product as directed.The complaint sample was returned for evaluation and the results of the chemical testing performed were consistent with shelf life limits.

Event Description

Additional event information was provided by the hospital doctor and the ophthalmologist that treated the patient in (b)(6) 2016.The chief complaint reported was bilateral eye irritation and inflammation after patient accidentally used hydrogen peroxide solution directly in his eye.The history noted that the patient had both keratoconus and diabetes.On the day of the event, the patient reported he accidentally put hydrogen peroxide solution into his eye when taking his contact lenses out.Instead of saline, the patient used the hydrogen peroxide solution in question on the plunger to remove his contact lenses and noted that it made contact with his eyes.The patient noted he had an acute onset of some mild to moderate irritation bilaterally, with the left eye greater than right eye.The eyes continued to be very inflamed and irritated.The consumer noted he had no complaints of any visual changes except that his vision seemed slightly cloudy on the left.No double vision was reported, and the patient denied any severe eye pain.The eye exam showed conjunctival injection, left eye greater than right with moderate conjunctival injection in the left eye and minimal in the right.White light exam of the corneas were normal bilaterally, except that the patient was reported to have a silicone implant in the left eye, which was reported to be ¿stable due to his keratoconus.¿ a slit-lamp exam was performed.No anterior chamber cell or flare was noted bilaterally.There was no evidence of any sort of corneal foreign body or obvious corneal trauma.The patient had a fluorescein exam done in both eyes and there was no evidence of any fluorescein uptake in the right eye.The left eye had some minimal punctate keratitis, but no evidence of any sort of significant ulceration or laceration to the eye.The clinical impression was that the patient had acute-moderate chemical conjunctivitis in both eyes, with the left eye greater than right eye.In addition there was an acute-mild left eye keratitis.Polytrim ophthalmic drops and erythromycin ophthalmic ointment were prescribed.An evaluation by the ophthalmologist was recommended and the patient was discharged home in good condition.The ophthalmologist recommended by the hospital was seen on the same day of the hospital doctor¿s evaluation.Information obtained from the ophthalmologist indicates the patient presented with bulbar injection, conjunctivitis, and corneal edema, although specifics on each eye were not provided.Corneal staining was present at a previous incision site.Dehiscence of wound was also noted.The wound/incision site is associated with an earlier and unrelated event and is not connected to the product in question.Additionally, information obtained from the ophthalmologist indicated the patient had a corneal abrasion that penetrated bowman's membrane and involved the ring tract of the patient¿s aforementioned incision site.Ophthalmologist also noted there was an infectious corneal ulcer (microbial keratitis), but it was not in the central 6 mm of the cornea.Specifics on each eye were not provided and cultures were not taken.The primary diagnosis was corneal abrasion.Antibiotics were reported to be prescribed.Ophthalmologist explained that consumer irritated his eyes by rubbing them so intensely that it lead to an abrasion and then ultimately to an infection.The ophthalmologist indicated the event was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Patient is recovered.

• 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: 6353473
• MDR Text Key: 68158402
• Report Number: 0001313525-2017-00417
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 00310119038178
• UDI-Public: 310119038178
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Lot Number: GE16013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2016
• 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: SCLERAL LENSES, REFRESH DROPS, ADDIPAK SALINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR