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

Lot Number GA16036

Device Problem Product Quality Problem (1506)

Patient Problems Conjunctivitis (1784); Edema (1820); Unspecified Infection (1930); Irritation (1941); Itching Sensation (1943); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Discharge (2225)

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

Consumer reported experiencing burning and redness.Consumer continued to use product and reported that she developed an infection, which she believed to be pink eye.Consumer stated that the symptoms of the reported infection were burning, light sensitivity and discharge.Consumer visited an urgent care center and was prescribed vigamox.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 punctuate staining of the cornea, decreased vision, corneal opacity and edema.¿ the symptoms of burning, redness and discharge (lacrimation) reported are consistent with the (b)(6) description of a temporary condition associated with hydrogen peroxide exposure.The consumer reported that the issue has resolved.Medical documentation was not provided.The complaint sample was not returned for evaluation.

Event Description

Consumer reported that she had used the product for years without issue; however, she developed an issue after she purchased a twin pack.With the first bottle, the consumer reported she experienced burning and redness.With the second bottle she thought she had "pink eye" and referred to her condition as an infection.She stated that the symptoms of the reported infection were burning, light sensitivity and discharge.Consumer visited an urgent care center and was prescribed vigamox.Consumer was unable to say if a diagnosis was provided at this time.Consumer only recollected telling the health care provider that she believed the infection to be pink eye.After the eyes cleared up, the consumer again reported that she used the product and experienced symptoms of burning, light sensitivity and discharge.The consumer did not visit a doctor for this event.She used the remaining vigamox in her possession and the symptoms resolved.Consumer has since switched contact lens solutions and has not experienced any further issues.Consumer is recovered.Medical documentation was not provided.The event described is consistent with the application of unneutralized hydrogen peroxide coming in contact with the eye.

Event Description

Medical documentation obtained from treating physician assistant at urgent care facility indicates patient presented with complaints of eye redness, eye irritation, eye itching, eye mattering, and blurred vision.During eye exam, conjunctival edema was noted in the right eye along with right eye injected conjunctiva, exudate, and erythema.Cornea was not involved.Patient was diagnosed with right eye conjunctivitis and prescribed vigamox.Practitioner believed the event was incidental to contact lens wear.

• 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: 6266614
• MDR Text Key: 65457189
• Report Number: 0001313525-2017-00135
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Lot Number: GA16036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 24 YR