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 Eye Injury (1845); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Visual Disturbances (2140); Eye Pain (4467)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 01oct2020 an on-line distributor reported a patient (pt) advised the ¿lenses infected¿ and irritated the od on (b)(6) 2020.The pt reported the eye care provider (ecp) diagnosed a ¿scratched cornea¿ due to the lenses.The product is reported as the acuvue® oasys® for astigmatism brand contact lenses (cls).Multiple calls were placed to the pt for additional medical and product information, but nothing additional was received.The pts medical event was determined as a non-serious medical event to the fda with the limited medical information provided.No additional medical information was received.On 07may2021 additional information was provided by the on-line distributor.The pt advised that a ¿right contact cut my cornea¿ and the pt had to go for an eye exam.The pt reported redness, severe pain, and an eye patch over the affected eye, day and night for a week.The pt reported, ¿wasn¿t able to see out of that eye for a while¿.Multiple attempts to reach the pt for additional medical and product details, but nothing additional was received.The pts medical event was determined as a non-serious medical event to the fda with the limited medical information provided.No additional medical information was received.On 08oct2021 a call was received from the pt who provided additional information.The pt reported ¿wearing a lens¿, and experienced pain on insertion.Later in the day the pt removed the suspect lens.The pt inspected the cls and reinserted it but continued to have irritation.The pt tried to ¿maneuver¿ the suspect cls in the eye, removed the lens again, cleaned and reinserted the lens.Later in the evening the pt removed the suspect lens and noted redness.The pt reported the cls tore while removing it.The pt went to the ecp the following day.The ecp diagnosed a ¿corneal abrasion¿ and prescribed an unknown medication.The pt has returned to cls wear but wears a different cls brand.On 12oct2021 another ecp at the office provided additional medical information.The pt was seen on (b)(6) 2020 for ¿hurt and irritated¿ od.The pt was also seen 4 months earlier ((b)(6)) for a regular eye exam and everything was normal.The pt was diagnosed with recurrent corneal erosion, questionable; it was pretty large, about 60% of the cornea.The pt was prescribed erythromycin ointment tid for 7 day and instructed to return in 2 days.The pt didn¿t return in 2 days for the follow-up.The pts od va was not taken at the time of the initial visit and pt was not seen after that.The ecp was unable to advise if the pt had any change in va or permanent damage to the od.On 12oct2021 the pts medical records were received.Date of visit: (b)(6) 2020; chief complaint: od hurts and is irritated.Od exam: conjunctival injection; cornea: rce (undetermined); pt prescribed ¼ ribbon erythromycin od in office.Assessment: ¿rce ? od¿; plan: return in 2 days, cornea recheck.On 13oct2021 a call was placed to the pts treating ecp who provided additional medial information.The ecp treated the pt with a bandage cls and pt was to follow-up in a few days, but the pt didn¿t return.The ecp confirmed the diagnosis of od recurrent corneal erosion, ¿almost the entire cornea was peeled off.¿ the ecp thinks the pt removed the bandage cls as the pt didn¿t return for the follow-up visit.The pt was seen about a week ago and everything seemed ok, no permanent damage, no affect to va.With the receipt of the additional medical information and diagnosis of od recurrent corneal erosion, the od event was determined to be a serious reportable medical event to the fda no additional medical information was received.No additional medical information is expected.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 b00tl4q was produced under normal conditions.The suspect od cls was discarded.No additional evaluation can be conducted.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
• MDR Report Key: 12751891
• MDR Text Key: 284030876
• Report Number: 1057985-2021-00166
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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: B00TL4Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention