MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE ¿ IRELAND ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TAS

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

Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 08/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 01oct2019, an email was received from (b)(6) with adverse incident report reference # (b)(4).A patient (pt) in the (b)(6) was diagnosed with a corneal ulcer in the right eye (od) while wearing an unspecified acuvue brand daily disposable contact lens (cl).The pt was treated (unspecified) and made ¿good recovery,¿ but will not wear cls again until november.On (b)(6) 2019, the pt was contacted, and additional information was received.The pt confirmed wearing an acuvue® oasys® 1-day for astigmatism with hydraluxe¿ technology brand cl.On (b)(6) 2019, the pt inserted the od cl and experienced discomfort, pain, and light sensitivity by early afternoon, which worsened throughout the day.On (b)(6) 2019, the pt awoke with pain, redness, and light sensitivity in the od.The pt saw a general practitioner who advised that there was an ¿infection,¿ prescribed chloramphenicol ointment 4 times daily, and referred the pt to the hospital.On (b)(6) 2019, the pt visited the eye department of the hospital and was diagnosed with a corneal ulcer, 2mm diameter, approximately 8 o¿clock in mid-periphery.The pt was prescribed hourly levofloxacin and chloramphenicol 4 times a day.On (b)(6) 2019, the pt returned for a follow-up visit and was advised the od was healing well and to continue same treatment.At the follow-up visit on (b)(6) 2019, the pt was advised to reduce levofloxacin use.At the follow-up visit on (b)(6) 019, the pt was advised to stop all treatment and was discharged.The pt was instructed to discontinue cl wear for 3 months.The pt reported that the vision was not affected.Pt admitted to occasionally napping in cls and wearing for ¿a little too long.¿ no further information was provided.The suspect od cl was discarded.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 l003pwt was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9221480
• MDR Text Key: 169728378
• Report Number: 9617710-2019-00037
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K042275
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: TAS
• Device Lot Number: L003PWT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention