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); Irritation (1941); Red Eye(s) (2038); Discomfort (2330)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 a call was received from a prescribing eye care provider (ecp) in (b)(6) who reported a patient (pt) had a ¿red-hot fire feeling¿ in the od that caused discomfort while wearing (b)(6) for astigmatism brand contact lens.The pt immediately removed the lens, and reported stinging, redness, and light sensitivity.The pt went to the emergency department and was advised ¿the lens stripped the top line of the cornea¿.The pt was prescribed eye drops and cream, but the ecp did not have the medication names or frequency prescribed.The pt was advised to discontinue contact lens wear for a couple of weeks.The ecp advised the redness has improved and the od feels more comfortable.The pt has a follow-up appointment next week.On (b)(6) 2019 the ecp called to report the medication prescribed was chloramphenicol 1% eye ointment, every 2 hours for the first 2 days and every 4 hours for a total of 7 days.On (b)(6) 2019 and email was received with additional medical information: a call was placed to the pts ecp who reported severe stinging/redness on insertion of a new od (b)(6) for astigmatism brand contact lens on (b)(6) 2018.The pt reported the symptoms were similar to inserting a lens with an un-neutralized h202 solution, though the longer reaction seemed different.The pt went to a hospital and was advised the pt ¿stripped the top layer of the cornea off.¿ the pt reported the vision was not affected during the event.Pt was prescribed chloramphenicol 1% ointment every 2 hours for first 2 days, then every 4 hours for the remaining 5 days of treatment.Pt was discharged from the hospital clinic last week (date of discharge is unknown) and advised it was ok to return to contact lens wear.The pt was prescribed artificial tears eye drops for use as needed.The pt does use an h202 system (brand was unknown) to clean and disinfect the lenses.The pt reported the suspect lens was fresh from the package and it had not been in any solution prior to insertion in the od.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 b00qbrj was produced under normal conditions.One lens was received in an opened blister.The parameters of the open lens were measured and a visual inspection was performed.The open lens met company standards for base curve, center thickness, and diameter.No visual attributes were revealed.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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8294494
• MDR Text Key: 134703702
• Report Number: 1057985-2019-00015
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

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: 04/01/2023
• Device Catalogue Number: CYP
• Device Lot Number: B00QBRJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention