MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC. - US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 27dec2017 a johnson and johnson sales representative in (b)(6) reported a patient (pt) while wearing an unknown acuvue brand contact lens was diagnosed with ¿corneal endothelial cells decreased close to 1000 (affected eye not provided)¿.The eye care provider (ecp) advised the pt that a ¿corneal transplantation is to be necessary when the pt has cataract surgery sometime in the future¿.The ecp reported that the pt purchased contact lenses on the internet without a prescription and had an eye exam for the first time in many years.On 10jan2018 a call was placed to the sales representative and additional information was provided: the sales representative reported the information was received from the ecp on 27dec2017.On jan.10, 2018, the cr supervisor contacted our rep.The rep reported as follows: the suspect brand was not provided.The pt contact information was not provided.The pt was advised by the ecp regarding the importance of routine eye exams.On 15jan2018 the sales representative provided additional information: the pt presented to the clinic and did not bring the suspect lens.It is unknown what contact lens brand the pt was wearing at the time of the event.Additional information was requested.No additional information has been received.The event date is unknown.The lot number is unknown.It is also unknown if the suspect product is available.The event is being reported as a worst-case event as the diagnosis and treatment were not confirmed with the pts treating ecp.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

On 24jan2018, our affiliate in (b)(6) received additional information from the johnson and johnson sales representative.The sales representative obtained the following information from the representative of the ecp: pt did not return for a f/u visit.The product is unknown as the pt did not bring the lens in question.The pt was previously prescribed 1-day acuvue define at the clinic.The ecp representative reported the pt ¿might wear a competitive color cl and called it ¿define¿.¿ no eye disorder was confirmed.No additional information has 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.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 7206649
• MDR Text Key: 97795944
• Report Number: 1057985-2018-00008
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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: 12/27/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 02/20/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention