MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

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

Patient Problems Keratitis (1944); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter's phone number: (b)(6).

Event Description

On (b)(6) 2018 an eye care provider (ecp) in (b)(6) reported a patient (pt) had red and swollen eyes while wearing the 1-day acuvue moist brand contact lens. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported discomfort after wearing the lens ou for a ¿period¿. The symptoms continued after the suspect lenses were removed. The following day the pt presented to the ecp and was diagnosed with keratitis. The pt was prescribed tobramycin-dexamethasone 5-6 times a day until recovery. The pt reported the eyes have not yet recovered. The event date was reported as (b)(6) 2018. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes were still red, but not painful. Pt can¿t use this contact lens any longer. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt has not been back to the ecp for a follow-up visit, so pt is unsure if the keratitis ou has resolved. Pt reported ou redness but has no eye pain. Pt continues to apply the tobramycin-dexamethasone eye drops ou and follows the recommended dosage. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes felt better, but ou redness remains. Pt stated the ecp advised the redness will resolve gradually with rest. The pt continues to apply the tobramycin-dexamethasone eye drops as previously prescribed. The pt has not been back to the ecp for a follow-up visit, but will return to the ecp if the symptoms do not resolve. This report is for the left eye (os) event. A separate report will be filed for the right eye (od) event. The suspect lens 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 5170830104 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed. Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY 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: 8086763
• MDR Text Key: 127868743
• Report Number: 9617710-2018-05068
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1DM
• Device Lot Number: 5170830104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 11/19/2018 Patient Sequence Number: 1