MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE ¿ USA UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Dry Eye(s) (1814); Red Eye(s) (2038); Discharge (2225)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, a patient (pt) called to report ¿pink eye¿ in the right eye (od) while wearing 1-day acuvue oasys for astigmatism contact lenses (cls).On (b)(6) 2018, the pt reported initially experiencing discharge, dryness, and redness during cl wear od.The pt does not sleep in the cls.The pt reported presenting to their eye care professional (ecp) on (b)(6) 2018, was prescribed tobramycin 1 gtt od q4h for 7 days and was to return for follow-up a few days later.The suspect product was discarded.On 03apr2018, the treating ecp was contacted and stated that there is no mention of cl causing ¿pink eye¿ in the pt¿s medical record notes and that ¿bacterial conjunctivitis can come from anywhere.¿ ecp refused to provide additional information.Multiple attempts were made for additional information.The pt provided lot number b00nk9t as the suspect lot; lot b00nk9t does not match the brand name that the pt reported.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 b00nk9t was produced under normal conditions.It is unknown what lot number or brand name of cls was involved in the event.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE ¿ USA; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256
• MDR Report Key: 7473912
• MDR Text Key: 106958995
• Report Number: 1057985-2018-00068
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

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 Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR