MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 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 Pain (1994); Red Eye(s) (2038); Uveitis (2122)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, a patient (pt) called to report ¿lasting redness¿ while wearing the acuvue oasys 1 day with hydraluxe brand contact lens.The pt recently changed from the acuvue oasys brand contact lens to the acuvue oasys 1 day with hydraluxe brand contact lens.On day 6, the pt noted a ¿prickly¿ feeling in the od.The pt removed the suspect od lens on arrival home but the ¿prickly¿ sensation, photophobia and eye pain continued.The pt went to sleep for a few hours and the symptoms worsened.The pt went to the eye care provider (ecp) the next day and was diagnosed with od uveitis.The pt was prescribed prednisolone eye drops qid for 6 days.The pt will follow-up with the ecp next week and reports will likely be put on a taper schedule for the eye drops.The pt reported the od was feeling much better today after starting the prednisolone eye drops, but still has some photophobia.The pt has not had a diagnosis of uveitis in the past.The pt does not sleep in the lenses.Multiple calls were placed to the pts treating ecp¿s office and additional medical information was requested, but no information was provided.No additional medical information has been received.The suspect od contact lens was discarded by the pt.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 j001scn was produced under normal conditions.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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8249907
• MDR Text Key: 133227555
• Report Number: 1057985-2019-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2018

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: 11/01/2023
• Device Catalogue Number: TSP
• Device Lot Number: J001SCN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR