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

Catalog Number PH

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

Patient Problem Corneal Ulcer (1796)

Event Date 09/01/2023

Event Type  Injury  

Event Description

On 21nov2023, an email was received from an on-line distributor who advised a patient (pt) developed a corneal ulcer (affected eye not provided) while wearing an acuvue® oasys® brand contact lens (cl).The distributor reported the pt ¿had many issues with the lenses since their last order in september, and developed an ulcer on their eye¿.The pt went to an eye care professional (ecp) who suggested, ¿it is from the lenses¿.The date the pt reported the event to the on-line distributor was 16nov2023.The distributor provided 2 lot numbers for acuvue® oasys®; lot numbers b014pxm and b014w2z.No additional information was provided.Multiple attempts were made to the pt by phone and email for additional medical and product information on 22nov2023, 28nov2023, and 05dec2023, but nothing additional has been received.The affected eye is unknown.The actual date of the corneal ulcer event was not provided but will be reported as 01sep2023.This corneal ulcer event is being reported as a worst-case as we were unable to verify the pt¿s diagnosis and treatment with the treating ecp.The suspect lot number could not be confirmed and will be reported as an unknown lot number.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number b014pxm was produced under normal conditions.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number b014w2z was produced under normal conditions.It is unknown if the suspect cl is available for return for evaluation.No additional evaluation can be conducted.If any further relevant information is received, a final report will be filed if appropriate.

Manufacturer Narrative

H3 other text : unknown if suspect product available.

• Brand Name: ACUVUE® OASYS®
• 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 ; 9047429918
• MDR Report Key: 18324373
• MDR Text Key: 330481007
• Report Number: 1057985-2023-00091
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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