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

Catalog Number PH

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

Patient Problems Corneal Scar (1793); Keratitis (1944); Local Reaction (2035); Corneal Infiltrates (2231)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 17-nov-2021 a patient (pt) in (b)(6) reported a diagnosis of od keratitis while wearing the acuvue® oasys® brand contact lens (cls).The pt is under medical supervision and was prescribed an unknown antibiotic, steroid, and additional unknown eye drops.No additional medical information was provided.On 19-nov-2021 additional information was provided.The pt reported using two lenses.It is unknown if the two lenses were for the od.The pt was prescribed floxal, dicloabak, corneregel, dexafree, artelac, rebalance and saline ¿for washing.¿ the frequency and duration of the prescribed eye drops are unknown.The pt reported currently the ¿surface of the cornea is smooth again and the inflammatory infiltrate has healed.There is still corneal opacity.¿ the pt didn¿t notice anything unusual with the od suspect cls.No additional medical information was provided.The date of event is (b)(6) 2021.No additional medical information has been received.No additional information is expected.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 l004x5v was produced under normal conditions.The suspect os cls was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 08dec2021, additional information was provided by the patient (pt).The dosage of the eye drops prescribed were provided.First week: floxal 6 times/day; dicloabak 4 times/day; corneregel 6 times/day.Second week: floxal 4 times/day; dicloabak 3 times/day; corneregel 4 times/day; dexafree two times/day.Third week to fourth week: corneregel 4 times/day; dexafree 2 times/day; artelac rebalance 3 times/day.Fifth week: obecnie (currently).Corneregel once time/day; dexafree 2 times/day; artelac rebalance 3 times/day.The pt did not provide the contact details for the prescribing eye care provider.No additional medical information has been provided.No additional medical information is expected.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS®
• 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: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12917929
• MDR Text Key: 282727163
• Report Number: 1057985-2021-00175
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L004X5V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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; Other