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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a call was received from an eye care provider (ecp) in germany who reported a patient (pt) is a new wearer for the acuvue oasys brand contact lenses and given trial lenses in the left eye.The pt called the ecp to report on removing the suspect lens the left eye was red.The ecp reported the pt will come in next week for an eye check.On 21dec2017 a follow-up call was placed to the ecp and additional information was obtained: the pt came into the store on (b)(6) 2017 to try the lenses again.Pt wore the lens for a few hours and returned to the store.The left eye suspect lens was removed and the conjunctiva was red.The pt had not yet visited an eye care provider for an evaluation.On (b)(6) 2018 a return call was placed to the reporting ecp who advised the pt went to an ecp.The pt was diagnosed with bacterial conjunctivitis and advised not to wear contact lenses for at least four weeks.Pt was prescribed ¿antibiotics and a cream¿.On 05jan2018 a follow-up call was placed to the pts reporting ecp and additional information was provided: the ecp didn¿t have the pts treating ecp information, but advised it will be requested from the pt.On 08jan2018 an email was received from the pts reporting ecp and additional information was provided: the pt was prescribed floxal 1 drop qid for 6 days, then return for follow-up eye exam.Pt was also prescribed hylocare and a vitamin a supplement to support treatment.On 17jan2018 an additional call was placed to the pts treating ecp who reported no additional medical information was available.The ecp reported the pt had a follow-up appointment after four weeks with no contact lens wear.On 26jan2018 a call was placed to the pts reporting ecp and additional information was provided: the ecp reported the pt has not returned and no additional medical information was provided.The suspect lenses were sent for return.No additional medical information has been received.Additional information has been requested.This report is for the pts left eye event.The event for the pts right eye will be submitted in a separate report.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 l003dd7 was produced under normal conditions.The suspect product has been requested, but it has not been received.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

One opened contact lens case was received which contained one lens.The lenses met company standards for base curve, center thickness and diameter.A visual inspection revealed a surface tear.

• 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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7229115
• MDR Text Key: 98607151
• Report Number: 9617710-2018-05008
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: PH
• Device Lot Number: L003DD7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention