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

Lot Number GG15044

Device Problem Product Quality Problem (1506)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Discharge (2225); Discomfort (2330); Eye Burn (2523)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The reported symptoms of burning and redness and the diagnosis of a chemical conjunctivitis are consistent with application of unneutralized hydrogen peroxide coming in contact with the eye.The (b)(6) 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 event reported is consistent with the (b)(6) description of a temporary condition associated with hydrogen peroxide exposure.The complaint sample was not returned for evaluation.

Event Description

Upon initial use of the product, the consumer reported a symptom of burning in her right eye when the lens was inserted.The consumer reported being seen by her doctor for an evaluation and being diagnosed with a corneal burn in her right eye.The medical evaluation by the doctor indicated that the patient presented with redness and burning/pain of the right eye.The practitioner diagnosis was a chemical conjunctivitis.Maxitrol (antibiotic) drops were prescribed.A follow-up examination two days after the initial evaluation revealed that the patient was doing well and the maxitrol drops were to be tapered off.Consumer reported following-up with her doctor two weeks later as she was continuing to experience dry eye, discomfort, blurry vision, and discharge in her right eye.Consumer stated that the doctor advised her to continue using maxitrol.According to the consumer, the doctor informed her that her eye would recover with use of the medication.

• 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: 6581718
• MDR Text Key: 75645044
• Report Number: 0001313525-2017-02523
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Lot Number: GG15044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2015
• 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: BIOFINITY CONTACT LENSES AND BIOTRUE SOLUTION
• Patient Age: 49 YR