MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Pain (1994); Blurred Vision (2137)

Event Type  Injury  

Event Description

On (b)(6) 2018, a maude data search revealed the following complaint from a patient (pt) while using an unknown acuvue brand contact lens (cl) with renu sensitive multi-purpose solution.The event country is unknown.Mdr report key: (b)(4); report number: 0001313525-2018-00095.The pt reported eye pain and blurry vision during cl wear, after using renu sensitive multi-purpose solution for several days.The pt reported being examined by an ophthalmologist at a local eye clinic and was diagnosed with a corneal burn, which was treated with antibiotics.The pt reported that since the issue had not resolved in 2 weeks, the pt was referred to a general hospital.On (b)(6) 2018, a medical certificate from the hospital indicated that the pt was diagnosed with ¿unspecified keratoconjunctivitis and corneal abrasion¿.The doctor comment on the certificate stated, "the patient was diagnosed as above after changing lens care solution and was treated for the events.Regular follow up visit is required".On (b)(6) 2018, the pt reported that ¿both eyes were affected and that the doctor from the hospital considered the event to have been caused by the lens care solution; however, causality speculation was not indicated on the medical certificate¿.The pt reported that the next follow-up visit would be mid-june 2018.The pt reported that the symptoms began immediately upon insertion of the cls.The pt reported that ¿corneal removal was done on the area of burn¿ and the pt was ¿prescribed a drop to generate the cornea,¿ along with orocin eye drops.The pt also reported that the treatment at the hospital included hyaluronate eye drops for dry eyes.The pt reported currently experiencing dry eyes and decreased visual acuity.On (b)(6) 2018, the pt reported that ¿both eyes were diagnosed with a corneal abrasion and keratoconjunctivitis, and the left eye was more severe¿.The pt reported wearing daily acuvue brand cl (unspecified).The pt reported that the cls had been worn for ¿two days consecutively when the event occurred, the lens was replaced the prior day, and the symptoms started on the second day she wore the lenses¿.The pt reported not sleeping in the cls.The pt reported visiting the first local eye clinic twice, then visiting a second local eye clinic, before finally being referred to the hospital.The pt reported that ¿the corneal cells were reported to have been removed at the first visit to the hospital".The pt refused to provide medical certificates or records from the two local clinics that completed initial evaluations.This report is for the left eye (os) event.A separate report will be filed for the right eye (od) event.The suspect cl availability is unknown.No product or lot information was available.No analysis could be conducted.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; +904443364
• MDR Report Key: 7677701
• MDR Text Key: 113671232
• Report Number: 1057985-2018-00090
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RENU SENSITIVE MULTI-PURPOSE SOLUTION
• Patient Outcome(s): Other; Required Intervention