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 Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2019, an email was received from an optical shop representative in (b)(6) who reported a patient (pt) was diagnosed with a corneal ulcer while wearing an acuvue brand contact lens (cls).On (b)(6) 2019, a call was placed to the pt and additional information was provided: the pt reported on (b)(6) 2019 after 3 weeks of wearing the acuvue oasys brand contact lens, the right eye (od) became painful and red.The pt reported the suspect cl was removed immediately.On removal of the od cl the pt reported eye pain, like a knife stabbing in the eye.The pt also noticed a ¿little spot¿ on the od at about 3 o¿clock.The pt went to an eye care provider (ecp) on (b)(6) 2019 and was diagnosed with an od corneal ulcer.The pt was prescribed cilodex every 2 hours for 2 days, then every 3 hours for 7 days.The pt was also prescribed epitegel to use nightly until the ecp return visit on (b)(6) 2019.The pt reported that once the medication was started, the symptoms improved by (b)(6) 2019.The pt reports that the ¿small spot¿ on the od is slightly smaller and experiences a burning sensation.The pt is currently wearing glasses and the ecp recommends the pt not return to cls wear.The pt replaces the cls ¿within less than 3 months of wear¿ and does not sleep in the cls.The pt can¿t recall which cl solution is used to disinfect the cls.On (b)(6) 2019, a call was placed to the pt¿s treating ecp and additional medical information was provided: the pt was diagnosed with an infectious peripheral corneal ulcer at 9 o¿clock.On the last visit on (b)(6) 2019, the corneal ulcer was not completely healed but has improved.Treatment continues with cilodex every 3 hours and epitegel tid.The ecp reported that once the corneal ulcer resolves, the pt will be re-evaluated for a return to cl wear.No additional medical information was provided.On (b)(6) 2019, a call was placed to the pt and additional information was provided: the pt has a follow-up appointment with the ecp on (b)(6) 2019 and has not been released to return to cl wear.Pt advised that the od feels better and the ¿spot¿ on the eye is very small.On (b)(6) 2019, a call was placed to the pt and additional information was provided: the pt visited the ecp today and was released from care and allowed to return to cl wear.The pt was advised to continue using lubricating drops.The pt was informed by the ecp that there is a scar on the od.The pt reported that the od is no longer painful and feels much better.The suspect product was requested for return for evaluation, but it has not yet 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 l003ksr was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One lens was received for lot # l003ksr.The lens was received in an open contact lens storage case.The product evaluation indicated that the suspect lens met company standards for base curve and center thickness.A microscopic visual exam indicated no abnormalities.The lens measured out of specification for diameter.The product was returned opened; 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.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: 8617808
• MDR Text Key: 145483971
• Report Number: 9617710-2019-00012
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: PH
• Device Lot Number: L003KSR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Date Manufacturer Received: 06/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR