MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Foreign Body Sensation in Eye (1869)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021 a patient (pt) sent an email asking if it is safe to wear contacts beyond the expiration date.On (b)(6) 2021 the pt called to ask if contact lenses (cls) can be worn past the expiration date of nov2020.The pt was advised not to use the cls past the expiration date as sterility can't be confirmed.The pt reported using the (b)(6) 2 brand cls past the expiration date and developed ¿green pus¿ in both eyes.The pt went to the primary care physician (pcp) as the pt feared an ¿infection¿ and was prescribed polymyxin b sulfate/trimethoprim ophthalmic solution.The pt was advised to ¿use in whichever eye was affected,¿ 1 drop every 6 hours.The pt used the prescribed drops in both eyes due to ¿slight symptoms¿ in both eyes, but reports the od was worse than the os.The pt also thinks there is some loss of vision in the od.The pt stated the od still doesn't feel right and can tell a difference in the vision when wearing eyeglasses.The pt advised it has been ¿some time¿ since the last eye exam and had an eye appointment scheduled with a new eye care provider (ecp) for friday (b)(6) 2021, but the ecp rescheduled the appointment to (b)(6) 2021.The pt advised the pcp did not instruct the pt to return for a follow-up appointment and the pt returned to cls wear with a new pair of lenses (date not provided).The pt stopped wearing the cls ¿right away¿ because the eyes ¿felt funny¿.The pt has not returned to the pcp for a follow-up.The pt accessed the patient portal during the phone call to get additional information from the pcp visit.The date of pcp visit was (b)(6) 2021 and the diagnosis was bacterial conjunctivitis ou.On (b)(6) 2021 a call was placed to the pts treating pcp and a representative verified the pts diagnosis of bacterial conjunctivitis ou and prescribed polymyxin b sulfate/trimethoprim eye drops, 1 drop to both eyes every 6hrs.The representative will send the medical report.On (b)(6) 2021 a call was placed to the pt who reported an ¿emergency appointment¿ with an eye care provider (ecp).The ecp advised the pt there is a problem with the retina and the pt was referred to a retinal specialist.The pt reported the appointment is scheduled for monday.The ecp didn't see anything else wrong with the eyes at the time of the visit.The pt reports no known trauma to the eye.On (b)(6) 2021 the pts medical report was received via fax.Date of visit: (b)(6) 2021.Primary diagnosis: bacterial conjunctivitis of both eyes.Reason for visit: infection.Chief complaint: eye infection.Hpi: pt reports "gunk" in the morning and throughout the day, in od then os.Physical exam: no ocular exam performed.Prescribed: trimethoprim-polymyxin b (polytrim) 10,000 unit - 1mg/ml drop - 1 drop into both eyes every 6 hours.Assessment and plan: bacterial conjunctivitis, both eyes; polytrim rx given.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 l002t5c was produced under normal conditions.The suspect od cls was discarded by the pt.No additional evaluation can be completed.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11665012
• MDR Text Key: 245378478
• Report Number: 9617710-2021-00110
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: AV2
• Device Lot Number: L002T5C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention