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

Catalog Number PH

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

Patient Problems Bacterial Infection (1735); Dry Eye(s) (1814); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On 07nov2020 an email was received from an eye care provider (ecp) who reported a patient (pt) experienced a redness in the os while wearing the acuvue® oasys® brand contact lenses.On 10nov2020 a call was placed to the pt and additional information was provided.The pt advised the os was itchy and dry after 3 hours of wearing the suspect contact lens.Lubricant eye drops (name was not provided) were applied and the pt experienced some relief of symptoms.The pt removed the suspect lens after 5 to 6 hours of wear.The following day the os was swollen, red, painful and hard to open.The pt went to the ecp who diagnosed ¿eye bacterial infections¿ and prescribed an eye ointment and eye drops.The pt couldn¿t recall the name of the medication prescribed or the frequency the medications prescribed were not provided.The os is currently fine.The pt refused to provide the medical report.The date of event was (b)(6) 2020.This os event will be reported as a worst-case event as we were unable to verify the diagnosis or treatment.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 l004g2c was produced under normal conditions.The suspect os contact lens 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 blister was received from the customer which contained one lens for lot # l004g2c.The lens met company standards for base curve, center thickness and diameter.The lens measured out of specification for sphere power.A microscopic visual exam revealed an edge tear.This product was returned opened and it is not known what external influences may have contributed to this out of specification measurement.If any further relevant information is received, a supplemental report will be filed.Section h - 6: code 10 - testing of actual/suspected device.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 10931542
• MDR Text Key: 219194952
• Report Number: 9617710-2020-00021
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L004G2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention