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 Bacterial Infection (1735); Conjunctivitis (1784); Eye Pain (4467)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Requested for return, but not received.

Event Description

On 07jan2022 a representative at an eye care provider¿s office (ecp) in the (b)(6) advised a patient (pt) reported discomfort and pain while wearing the acuvue® oasys® for astigmatism brand contact lens (cl).The pt didn¿t notice anything unusual with the suspect cl.The pt only had issues with the os and was seen on (b)(6) 2021.On 11jan2022 the representative at the ecp¿s office called to provide additional information.The pt only experienced issues in the os.The pt was initially seen on (b)(6) 2021.On (b)(6) 2021 the pt returned wearing the cl and was diagnosed with a ¿mild bacterial conjunctivitis in os¿.The pt was advised not to wear cls for 3 weeks.The pt didn¿t seek any additional outside medical attention.The pt was advised by the treating optician to get ¿ drops¿ from a pharmacy or return if the condition worsened.The optician didn¿t prescribe any medication.The pts eyes are currently fine and the pt has returned to cl wear.On 19jan2022 additional information was provided.A representative reported the note from the optician in the medical chart states, mucus discharge, mild bacterial conjunctivitis, and no need for treatment.The pt was advised to return to the ecp if symptoms worsened and use over-the-counter artificial tears.The pt has returned to cls wear and the os is currently fine.No additional information was provided.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 b00w1tv was produced under normal conditions.No additional information has been provided.The suspect os cl was requested for return for evaluation, but it has not yet been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One opened lens case was received containing 2 lenses for lot #b00w1tv.Lens one was unable to be evaluated/measured as the lens was received torn in half.Lens two measured within specification for base curve, center thickness and diameter.A magnified visual inspection revealed a surface mark on lens two.This product was returned opened therefore it is not known what external influences may have contributed to this issue.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: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 13456624
• MDR Text Key: 285645311
• Report Number: 1057985-2022-00005
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: B00W1TV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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 Sex: Female