MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

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

Patient Problems Corneal Ulcer (1796); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 a patient (pt) from (b)(6) called to report os eye pain upon inserting the acuvue oasys®1 day with hydraluxe brand contact lens.The pt went to see a doctor who diagnosed an os corneal ulcer.The pt was prescribed tobramycin eye drops and recombinant human epidermal growth factor eye drops to use q 1 hour.On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt went to the eye care provider (ecp) on (b)(6) 2018 and advised the corneal ulcer has not resolved.The ecp prescribed norfloxacin eye drops every 2 hours.The pt was also advised to apply sodium hyaluronate eye drop as needed for discomfort.The medical report was requested.On (b)(4) 2019 a call was placed to the pt who refused to provide the medical report.No additional medical information has been received.The event date is reported as (b)(6) 2018.The os suspect contact lens was discarded.No evaluation can be conducted.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 5636560104 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2019 an email was received from the patient (pt) with receipts for medication prescribed for the reported event.Receipt dated (b)(6) 2019.Levofloxacin/ofloxacin 0.1 ml bottle.Artificial tears 15mg;5 ml bottle.On (b)(6) 2019 a call was placed to the pt to check the eye condition.The pt reported the left eye was recovered no additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 26feb2019 during a file review it was noted that there was a date error on mdr 9617710-2019-00001 follow-up # 1 submitted on 06feb2019.In section h.10."25dec2019" should be 25dec2018.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 8245621
• MDR Text Key: 132987479
• Report Number: 9617710-2019-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: TSP
• Device Lot Number: 5636560104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention