MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE 2 DEFINE; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number A2D

Device Problem No Apparent Adverse Event (3189)

Patient Problems Keratitis (1944); Pain (1994); Swelling (2091); Blurred Vision (2137); Excessive Tear Production (2235)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2018 a patient¿s (pt) family member in (b)(6) called to report that the pt experienced pain and swelling in both eyes soon after inserting the acuvue2 define brand contact lenses.Pt went to the hospital on (b)(6) 2018 and received treatment (treatment not provided).No additional information was provided.On (b)(6) 2018 a call was placed to the pt for additional medical and product information: pt is a new acuvue wearer.Pt put on the third pair of lenses on (b)(6) 2018 and experienced pain in both eyes on insertion.The pt waited a few seconds and the eyes were less painful.The pt left home and noted the vision was blurry on exiting the elevator.Pt removed the suspect lenses and the vision remained blurry.Pt went to the hospital and was advised the ¿cornea was seriously injured¿ and ¿blisters were all over the cornea¿.Pt was prescribed 3 eye drops, 1 of which was prescribed hourly.Pt reported some eye improvement on (b)(6) 2018, but vision is still not totally clear currently.Pt agreed to provide the medical report.The suspect lenses were requested for return for evaluation.On (b)(6) 2018 an email was received from the pt with the medical report and it was sent for translation.On (b)(6) 2018 a call was placed to the pt for additional information: pt reported he/she was prescribed tobramycin twice daily for 3-4 days.Pt has been using deproteinized calfblood extract eye gel four times a day; recombinant bovine basic fibroblast growth factor eye drops hourly.Pt reported the eye pain and swelling resolved after 3 days of treatment and the vision is better now, but vision is still not as clear as it used to be.Pt reported the eyes were painful and tearing ¿every second¿ on that day and reported needing assistance with any activities.Pt reported the eye care provider (ecp) did not request a follow-up visit.Pt refused to return the suspect lenses.Medical report translation received on (b)(6) 2018: date of visit: (b)(6) 2018.¿chief complaint: eyes pain for half a day.Used to wear contact lens.Physical examination: ou: blepharospasm, conjunctival congestion, corneal epithelial edema, corneal lamellar haze, fundus can't be seen.Diagnosis: keratitis.Prescription: recombinant bovine basic fibroblast growth factor eye drops; 1 bottle solcoseryl eye gel; 1 bottle, ou qn; tobramycin eye drops; 1 bottle, ou bid return visit tomorrow.Date of return visit: (b)(6) 2018.Chief complaint: eyes return visit.Physical examination: ou: conjunctival congestion, slightly swollen, partial repair of corneal epithelial, rest (-).Diagnosis: keratitis.Prescription: continue to use the original medicine.Recombinant bovine basic fibroblast growth factor eye drops; 2 bottles.No additional information has been received.This is for the pt's os event.The event for the pt's od will be submitted in a separate report.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 3626430104 was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On 26jan2018 our affiliate in (b)(6) placed a call to the pt and additional information was received: pt reported that he/she can see things normally now, but reported ¿cannot look at things for a long time¿.Pt visited the eye care provider (ecp) on (b)(6) 2018 and had no further ecp visits.Pt reported he/she may visit the ecp next week.Pt reported the vision recovered about 10 days after the event occurred.On 31jan2018 our affiliate in (b)(6) placed a call to the pt and additional information was provided as follows: pt had a follow-up visit to the eye care provider (ecp) on (b)(6) 2018 and reported the previous prescription was -2.50, which did not change for years.Pt reported currently the prescription is -3.30 and the eye sight is worse.The pt agreed to provide the medical report.No additional medical information has been received.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE 2 DEFINE
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 7219885
• MDR Text Key: 98279459
• Report Number: 9617710-2018-05007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: A2D
• Device Lot Number: 3626430104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention