MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 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 Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038); Swelling (2091); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 a patient¿s (pt) family member called to report a pt is allergic to the 1-day acuvue® moist® for astigmatism brand contact lens and had a reaction while wearing the lenses.The pt has seasonal allergies and had an ¿eye infection¿ over the past 2 weeks.The pt woke up one morning with the od swollen shut and went to a clinic who advised the pt had an ¿eye infection.¿ the pt was prescribed amoxicillin and an ¿eye drop¿ of which the details were not provided.The od didn¿t get better so the pt went to a hospital and an eye specialist.The eye specialist diagnosed the pt with the bacterial conjunctivitis od and the pt reported symptoms of red eye with ¿watery discharge, not mucus.¿ the pt was advised to stop taking the amoxicillin eye drops and was prescribed different eye drops, details were not provided.The family member reported the pt at one time ¿started wearing the lenses again and started having symptoms again.¿ the pt was not available at the time to provide additional medical information.The date of the event was reported as (b)(6) 2019.On 13sep2019 additional information was provided: the pt had a third appointment with the eye care provider (ecp), an ophthalmologist confirmed the pt is not allergic to the lenses but advised the pt had a ¿severe eye infection¿ caused by either bacteria or a virus.The pt has a fu appointment pending with the ecp next week and is hoping the pt will be cleared to return to contact lens wear.The family member reported the pt initially was advised it was an allergy to the lens, but the ophthalmologist concluded there is no lens allergy.Multiple calls were placed to the pt for additional medical and product information, but nothing additional has been received.A call was placed to the pts treating ecp and additional medical information was requested, but nothing additional has been received.The lot number is unknown.It is unknown if the od suspect lens is available for evaluation.No evaluation can be conducted.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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9078036
• MDR Text Key: 162272418
• Report Number: 1057985-2019-00085
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N18033
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1MA
• Device Lot Number: UNK-1MA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention