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); Conjunctivitis (1784); Corneal Scar (1793); Erythema (1840); Keratitis (1944); Visual Disturbances (2140); Corneal Infiltrates (2231); Eye Pain (4467)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

The suspect product was discarded.

Event Description

On (b)(6) 2021 a patient (pt) called to report a diagnosis of a ¿virus¿ in both eyes while wearing the acuvue® oasys® 1-day for astigmatism with hydraluxe¿ technology brand contact lens (cls).The eye care provider (ecp) advised the pt not to use the cls anymore.No additional information was provided.On 18jun2021 the pt provided additional information.The pt had discharge papers provided by the treating ophthalmologist which read, ¿bacterial keratitis and scar in the outside of the cornea, not affecting the vision in the os¿.The pt was prescribed moxifloxacin ophthalmic 1 drop qid os with an unknown treatment duration.The os event has resolved, but the pt has not returned to cls wear per the ecp recommendation.The pt will provide the medical report by email.The pt reports daily cls wear with a daily cls replacement schedule.On 21jun2021 the pt provided the medical report by email.Date of visit: (b)(6) 2020.Chief complaint: possible os eye infection, complains of photophobia and os eye pain.The pt may have had ¿os eye infection¿ since (b)(6) 2019, complains of eye pain, clear discharge, photophobia; pt began ciprofloxacin (b)(6) 2020 with some relief.Pt reports daily cls wear.Medications: ciprofloxacin 0.3%/dexamethasone 0.1% ear drops, 1 drop tid; ocuflox 0.3% eye drops, 1 drop q1h while awake os, prescribed (b)(6) 2020.Va os: 20/20-1; iop os: 8.Anterior exam os: lids, lashes, lacrimal: 1-2 + inj; conjunctiva: white and quiet; cornea: <1mm nasal central infiltrate; anterior chamber: deep and quiet.Assessment and plan: bacterial keratitis: (b)(6) 2020; prescribed: ocuflox 0.3% eye drops: (b)(6) 2020 , 1 drop every hour while awake os; no cl wear with acute infection; return in 1 week.Date of visit (b)(6) 2020: os cornea: scar, no epi defect.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 b00r8t2 was produced under normal conditions.The suspect os discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2021 during a file review it was noted that there was a date error on the initial mdr 1057985-2021-00143 submitted on (b)(6) 2021.In section a2, the patient¿s date of birth was noted as "(b)(6) 1973¿ but should be (b)(6) 1973.If any further relevant information is received, a supplemental report will be filed.

• 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
• MDR Report Key: 12169642
• MDR Text Key: 277184915
• Report Number: 1057985-2021-00143
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: TAS
• Device Lot Number: B00R8T2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 46 YR