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

Catalog Number 1MA

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

Patient Problems Conjunctivitis (1784); Itching Sensation (1943); Keratitis (1944); Discharge (2225); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 a call was received from a patient (pt) in (b)(6) who reported eye itching and discharge (affected eye not provided) while wearing the 1-day acuvue moist for astigmatism brand contact lenses.The pt went to an eye specialist who diagnosed conjunctivitis and keratitis and prescribed eye drops (details were unknown).The pt reported the eye improved.On 23dec2019 a call was placed to the ecp who provided additional information: the ecp reported the pt experienced discomfort while wearing the suspect lenses, however no additional medical information is known.On 23dec2019 a call was placed to the pt who provided additional information: the pt reported both eyes were affected.The pt reported the eye specialist prescribed: chloramphenicol ophthalmic solution, day and night; erythromycin eye ointment, day and night; tobrex sterile ophthalmic solution, every 3 hours; tears naturale lubricant eye drops, when eye feel dry; totifen ophthalmic solution (ketotifen), morning.The pt no longer has the medical report from the eye specialist.On 03jan2020 additional information was received from the pt: the pt confirmed the eyes have recovered, however there is a ¿white spot¿ on the right eye (od) which the doctor confirmed to be scar tissue.The pt is not experiencing any other issues.The pt is not able to provide a medical report.The pt is currently using contact lenses.No further information was provided.On 10jan2020 additional information was received from the pt: the pt stated the ¿white spot (scar tissue)¿ on the od has resolved and is no longer there.Both eyes are fully recovered.No further information was provided.No additional medical information has been received.The event date is unknown.This event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment.This report is for the od event.A separate report will be filed for the left eye (os) event.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 3048520104 was produced under normal conditions.The suspect od contact lens was discarded.No additional evaluation can be completed.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST FOR ASTIGMATISM
• 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: 9583201
• MDR Text Key: 184057362
• Report Number: 9617710-2020-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 1MA
• Device Lot Number: 3048520104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention