MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS FOR ASTIGMATISM; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number CYP

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Neovascularization (1978); Red Eye(s) (2038); Eye Pain (4467)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Product was requested but not received.

Event Description

On (b)(6) 2021 a patient (pt) in (b)(6) reported on social media a problem with an unknown acuvue brand contact lens getting blurry.The pt advised in less than 2 months all the lenses are ¿damaged in 2 days.¿ the pt put the lens in solution, went to get it and it was ¿square.¿ on 24may2021 the pt provided additional information.The pt reported redness and burning sensation ou while wearing the acuvue® oasys® for astigmatism brand contact lenses (cls).On removal of the suspect lenses, the pt noted both lenses were torn.The pt experienced ou pain and redness after removing the cls.On (b)(6) 2021, the pt went to an eye care provider (ecp) and was prescribed several eye drops and medications that were unknown at the time of the call.The pt reported no cls wear for 15 days and advised both eyes were better within 15 days.The pt reported daily cls wear with a 20-day replacement schedule and uses tap water to cleanse the cls case.The ecp advised the pt it was ok to return to cls wear with another cls brand.The pt is currently wearing the last pair of acuvue® oasys® for astigmatism brand cls without symptoms.The pt has a follow-up ecp appointment in 30 days.The pt provided an ecp note dated (b)(6) 2021; the pt did not adapt with the acuvue oasys for astigmatism cls with a base curve of 8.6, it was not the best choice.The pt was diagnosed with corneal ulcer ou and treated.Do not use the cls.On 25may2021 a call was placed to the pts treating ecp.A representative advised the pts initial visit was on (b)(6) 2021 and was prescribed vigamox, systane, and flutinol.On (b)(6) 2021, the pt had a follow-up ecp visit and acyclovir was added to pts treatment.No additional medical information was provided.On 26may2021 a call was placed to the pts treating ecp who provided additional medical information.The pt was initially treated with vigamox every 2 hours for the first week, then decreased to every 4 hours on the second week.The pt was prescribed systane lubricating drops every 6 hours and flutinol (frequency of treatment was not provided) in the pts 2nd week of treatment.The ecp added acyclovir as prophylaxis but was unable to confirm a herpetic event.The ecp also reported ou neovascularization.The ou corneal ulcer event is healed with central scarring.The pt was advised to discontinue cls wear due to the recent corneal ulcer diagnosis and requested to return for a new refraction.No additional medical information has been received.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 b00vw8w was produced under normal conditions.The suspect od cls was requested for return for evaluation but have not been received.This report is for the od event.A separate report will be filed for the os event.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 12021075
• MDR Text Key: 267899499
• Report Number: 1057985-2021-00139
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: B00VW8W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR