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 Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930); Irritation (1941); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, a patient (pt) reported discomfort and ¿slight pain¿ while wearing an acuvue oasys®1 day with hydraluxe¿ technology brand contact lens (cl) on (b)(6) 2020.The pt immediately experienced irritation upon inserting the cl from a new package.Upon removal of the cl, the pt continued to experience irritation and ¿slightly red eye.¿ no further information was provided.On (b)(6) 2020, additional information was received from the pt: the pt confirmed the issue occurred in the right eye (od).The pt reported that the od was better after removing the cl, and the pt used a new cl with no issue.The pt did not seek medical attention.The pt reported the od is currently fine.The pt reported a daily wear schedule and does not use any cl solution.No further information was provided.On (b)(6) 2020, an email was received from the pt with additional information: the pt reported initially thinking the redness reported on (b)(6) 2020 was ¿not so serious,¿ but soon after, the pt developed ¿serious¿ redness, light sensitivity and pressure and went to the doctor.The pt reported the od was ¿scratched on the brown part, and that part that was affected has turned into a white scar spot and unfortunately got infected as well.¿ the pt reported the od is currently recovering from the condition and extreme blurred vision due to the medicine, after about a week and a half.The pt visited two different eye care providers (ecp) for the ¿infection.¿ the pt is returning for follow-up with the second ecp on (b)(6) 2020.The second ecp advised the pt that a new cl prescription will likely be needed to help the blurred vision once the od is healed completely.Pt was advised by the ecp to discontinue cl wear.On (b)(6) 2020, a call was placed to the initial treating ecp office and a representative reported that the pt¿s issues were not related to cls.No further information was provided.On (b)(6) 2020, additional information was received from the pt: the pt confirmed that on (b)(6) 2020, the od experienced pain upon insertion.With the use of another cl in the od, the eye was fine.Soon after, the od became very red and photophobic, so the pt visited the initial treating ecp (unspecified date).The ecp informed the pt the ¿eye was injured¿ and the pt had a scar on the ¿brown eye¿ along with an ¿infection.¿ the pt reported experiencing blurry vision.The ecp advised the pt that the scar will not go away, and the vision will stay blurry.The pt reported being treated with eye drops to ¿open the pupil,¿ (unspecified medication) qid for 5-6 days for the pain and moxifloxacin 0.5% q2h for 5 days while awake, then to follow-up.At the follow-up visit with the initial ecp the moxifloxacin was changed to qid.The pt visited the initial treating ecp about 3 times, then went to the second ecp who changed the moxifloxactin to tid until the drops were gone.The pt was still experiencing blurry vision in the od.The second ecp advised the pt the blurry vision may have been caused by the medication, as the scar does not appear to be in the visual axis.No further information was provided.On (b)(6) 2020, additional information was received from the second treating ecp: the ecp reported that the pt was seen on (b)(6) 2020 as an emergency after the pt tried wearing a cl that caused eye pain.The corneal ulcer had resolved but a peripheral corneal scar remained.The ecp advised the pt to finish using the drops previously prescribed.The pt was seen for a follow-up visit on (b)(6) 2020 and the slight peripheral scar remained.The pt was advised to discontinue the eye drops.The ecp reported the scar is not in the visual axis nor will affect the pt¿s vision.On (b)(6) 2020, additional information was received from the initial ecp¿s office: a representative reported the pt visited the ecp on (b)(6) 2020 and was diagnosed with a corneal ulcer od described from a drawing as ¿on the outside border of the cornea and on top,¿ as well as irritation and light sensitivity.The pt was prescribed moxifloxacin qid for a week and cyclogyl gel qid for a week.The pt returned for a follow-up visit on (b)(6) 2020, where the pt was advised to stop using cyclogyl and to continue the moxifloxacin.The representative reported the pt¿s visual acuity was checked with glassed and was ¿normal 20/25 not affected.¿ the pt has a scheduled follow-up visit on (b)(6) 2020.No additional information has been received.One opened blister containing one contact lens was received for lot # j00261q.The parameters of the lenses were measured, and a visual inspection was performed.No visual attributes were observed.The lens met company standards for power, base curve, center thickness, and diameter.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 j00261q 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: 9723128
• MDR Text Key: 190331781
• Report Number: 1057985-2020-00011
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Device Lot Number: J00261Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR