MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

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

Patient Problems Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Excessive Tear Production (2235)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2020 a patient in the (b)(6) reported an ¿eye infection¿ following a contact lens trial of the 1-day acuvue® moist® brand contact lenses.On 26aug2020 additional information was provided.The pt reported eye pain that felt like a ¿pin under the lid¿ and scratchiness that didn¿t resolve during the night on (b)(6) 2020.The pt went to the hospital and was diagnosed with keratitis (affected eye not provided).The pt was prescribed exocin every hour for 2 days, then every 2 hours for 5 days, then 3-4 times a day.The pt was also prescribed chloramphenical eye ointment once daily for 14 days and hypromellose as needed.On 26aug2020 a report was received from the (b)(6) # (b)(4).The pt reported eye pain, on the third time while wearing the suspect lenses.The pt reported the pain became unbearable and went to the eye hospital for evaluation.The pt was advised to take a course of antibiotic eye drops and ointment to clear the ¿infection.¿ the pt had recently changed contact lens brands from a lens that never caused any issues to the 1-day acuvue® moist® brand contact lenses.On 03sep2020 a call was placed to the pt and additional information was provided.On (b)(6) 2020 the pt reported the keratitis event was for the os.The pt reported a new suspect lens was inserted in the os and it was discarded after 4-5 hours of wear.The pt didn¿t notice anything unusual with the os suspect lens.The pt has not yet returned to contact lens wear as the pt was advised to discontinue contact lens wear for 1 month.The pt reported later receiving a call from a different practitioner who advised the pt to now discontinue contact lens wear for 3 months.The pt agreed to provide the medical record from the (b)(6) 2020 event.On 07sep2020 the pt¿s discharge summary was received from the pt.Discharge date: (b)(6) 2020.Pt presented with complaints of ¿scratched feeling,¿ watering, light sensitive, foreign body sensation, redness in the os.The pt is a contact lens wearer.Va os aided: 0.12 (6/7.5).Investigation 01: eye swabs.Diagnosis: left contact lens related keratitis.Discharge medication: occ chloramphenicol 1% and, exocin 0.3% on hourly, hypremellose guttae prn, avoid cl wear.Discharge destination: residence.Discharge outcome: referred to a&e clinic.No additional medical information was provided.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 4017070103 was produced under normal conditions.The os suspect lens was discarded by the pt.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 10553774
• MDR Text Key: 215901753
• Report Number: 9617710-2020-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1DM
• Device Lot Number: 4017070103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37