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

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 a patient (pt) in (b)(6) reported discomfort (affected eye not provided) in (b)(6) 2017 while wearing the acuvue oasys 1 day brand contact lens.The pt reported wearing the suspect lens 30 to 60 minutes.The suspect lens was removed and the pt noticed the lens was torn.The pt reported the redness seemed to resolve the next day.The pt wore glasses.The pt developed eye swelling a few days after the event.On (b)(6) 2018 the pt went to an eye care provider (ecp) and was diagnosed with ¿bacteria in the eye and staining¿.The pt was prescribed eye drops, but refused to provide the name or frequency of the treatment.The pt reported the eye swelling is persisting.The pt refused to provide any additional medical information and refused the medical interview.No additional medical information was provided and 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 5523900106 was produced under normal conditions.The suspect product was discarded.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7253007
• MDR Text Key: 99589001
• Report Number: 9617710-2018-05013
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

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 Expiration Date: 06/01/2021
• Device Catalogue Number: TSP
• Device Lot Number: 5523900106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention