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

Catalog Number AV2

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

Patient Problems Corneal Ulcer (1796); Iritis (1940); Local Reaction (2035); Red Eye(s) (2038); Visual Disturbances (2140); Corneal Infiltrates (2231)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Product discarded.

Event Description

On (b)(6) 2020 a patient (pt) reported 6 acuvue¿ 2 brand contact lens have torn on a social media website.On 09dec2020 the pt called to report a diagnosis of od infected corneal abrasion on (b)(6) 2020.The pt advised it was unknown if the event was related to the contact lens or not as the pt was hit in the eye with a tree branch 10-12 days prior.The pt reported waking on (b)(6) 2020 with an od red eye.It was unknown if the organism was cultured.The pt was prescribed ofloxacin eye drops hourly and was advised to return to the eye care provider (ecp) in 24 hours.The pt advised the od didn't improve, so the pt was referred to a specialist.The specialist reduced the frequency of the ofloxacin to qid and added prednisone for the swelling.The pt was asked to return in 5 days and advised the od started to improve.The pt continue treatment for 3.5 weeks with no contact lens wear.The pt reported symptoms of red eye and photophobia.The od is currently fine.On 10dec2020 a call was placed to the pts treating ecp and a representative provided additional medical information.The pt was seen on (b)(6) 2020 and diagnosed with a corneal ulcer in the od.The pt was prescribed polysporin ointment at bedtime and ocufloxacin eye drops, 1 drop hourly for 24 hours.The pt was advised to return for a follow-up appointment the following day.The pt returned the following day and the pt was diagnosed with iritis, so the pt was referred to a specialist.On 11dec2020 a call was placed to the pts treating specialist for additional information.A representative reported the pt was seen for an od corneal ulcer (date of the visit was not provided).The pts chart indicated only infiltrate surrounding cells on the cornea.No additional medical information was provided.On (b)(6) 2020 a call was received from the pt with additional information.The pt was cleared to return to acuvue2 brand contact lens wear.On 16dec2020 an email was received from the pts treating specialist with additional medical information.The date of visit was (b)(6) 2020.The pt was diagnosed with a non-infectious central corneal ulcer od.The pt was prescribed prednisolone acetate qid od and ofloxacin qid od.The od event has resolved.It is unknown at this time if there is any permanent damage or loss of visual acuity.No additional medical information has been received.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 b00v5s1 was produced under normal conditions.The suspect od contact lens was discarded.No additional investigation can be conducted.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, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11058941
• MDR Text Key: 227913961
• Report Number: 1057985-2020-05002
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Device Lot Number: B00V5S1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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): Required Intervention
• Patient Age: 50 YR