MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Corneal Ulcer (1796); Irritation (1941); Itching Sensation (1943); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Excessive Tear Production (2235)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 02jul2019, a patient (pt) from (b)(6) called to report a diagnosis of a corneal ulcer in the right eye (od) while wearing an acuvue® 2® brand contact lens (cl).On (b)(6) 2019, the pt experienced itching and irritation with 1 cl in the od.The next day, the pt tried 2 cls in the od and within 3 hours of wear, experienced burning sensation and redness.Upon removal of the od cl, the pt experienced redness, burning, tearing, photophobia, and blurry vision like ¿a cloud in eye¿.On (b)(6) 2019, the pt visited an eye care provider (ecp) at a hospital and was diagnosed with a corneal ulcer od.The pt was prescribed flutinol (fluorometholone) every 2 hours for 10 days, and another medication (unspecified) every 6 hours for 5 days.The pt noted that the blurry vision is better now, however the pt is still experiencing burning, redness, tearing, and photophobia in the od.The pt has a return visit scheduled for (b)(6) 2019.The pt has not worn cls in the od for 15 days.The pt reported daily wear of cls with a replacement schedule of 1 month.The pt uses bausch and lomb renu solution to disinfect cls.On (b)(6) 2019, a call was placed to the treating facility and additional information was received: a representative of the treating facility reported that there is no record of the pt¿s visit on (b)(6) 2019.The pt was last seen on (b)(6) 2018 for a routine eye exam.No further information was provided.On (b)(6) 2019, a call was placed to the pt and additional information was received: the pt confirmed that treatment was received at the treating facility provided.The pt was unwilling to provide the treating ecp¿s name or information.The pt agreed to email with the name of the prescribed medication.The pt reported that the od is much better now, but the pt is still experiencing photophobia.No additional information was provided.On (b)(6) 2019, a call was placed to the pt and additional information was received: the pt reported that the ecp stated that the od is healing, and the pt will not have ¿further damage in her vision¿.The ecp advised that the pt can wear cls again and suspended the medication.The pt reported that the photophobia has resolved with no further issues.The pt has resumed cl wear and is currently wearing a different brand of cls.No additional information was provided.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified.The suspect od cl was discarded.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 l003p7t was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8818481
• MDR Text Key: 152034141
• Report Number: 9617710-2019-00026
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: AV2
• Device Lot Number: L003P7T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR