MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS® 1-DAY FOR ASTIGMATISM WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TAS

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

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796)

Event Date 04/16/2019

Event Type  Injury  

Event Description

On 09feb2022 a representative in (b)(6) at an eye care provider¿s (ecp) office reported a patient (pt) was diagnosed with an od bacterial corneal ulcer while wearing the acuvue® oasys® 1-day with hydraluxe¿ for astigmatism brand contact lens (cl).The date of event is reported as (b)(6) 2019.The pt was seen at their location on (b)(6) 2019 for a follow-up ecp visit.The pt was originally diagnosed at another location on (b)(6) 2019.The pt was originally prescribed besivance q2h for 2 days, then qid for the rest of the week.On (b)(6) 2019, the pt was advised to discontinue besivance and start lotemax qid for the 1st week, then decrease to bid for the 2nd week.The pt presented for an additional follow-up appointment on (b)(6) 2019 and it was noted that the bacterial corneal ulcer resolved.The pt was counseled on cl hygiene and wear.The representative refused to provide any additional information.No additional medical information has been received.The lot number of the suspect product is unknown.It is unknown if the suspect od cl is available for return for evaluation.No additional evaluation can be conducted at this time.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Unknown availability for od cl.

• Brand Name: ACUVUE® OASYS® 1-DAY FOR ASTIGMATISM WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY 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: 13536606
• MDR Text Key: 285644827
• Report Number: 1057985-2022-00006
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042275
• 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
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• 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