MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION - USA UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Abrasion (1789); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Eval: no testing methods performed; no results available since no evaluation performed; unable to confirm complaint; device not returned.

Event Description

On (b)(6) 2017 a patient (pt) called to report while wearing acuvue brand contact lenses (specific lens was unknown) under a rigid gas permeable lens for the past thirty years or so to treat keratoconus, he/she has had numerous issues.During the past thirty years, the pt reported he/she has worn different acuvue lenses.This report is for the pts corneal abrasions and "eye infections" event.Pt reported he/she did not think the events were related to the contact lenses, but due to the keratoconus.The pt reported in the past he/she was prescribed vigamox drops, polymyxin b and prednisone for the issues he/she experienced.Pt could not recall when or where he/she was treated for the event as he/she was treated at different eye care providers (ecp) in different states.On (b)(6) 2017 a call was placed to the pts treating ecps office and a representative reported additional information as follows: the representative reported the pts chart shows the pt is now being treated by a specialist for keratoconus.The pts history indicated corneal abrasions with scars, no dates were provided.Also noted the pt ¿has an extremely thin cornea".On visit date (b)(6) 2011, the pt stated he/she was seen by another ecp and advised the pt had a centrally located corneal abrasion with scarring od.The pt at that time was wearing a ¿hybrid lens¿ and it was not noted the pt was wearing an acuvue brand contact lens at that time.The pt the pt was transferred to a corneal specialist, the keratoconus is stable and to continue piggyback lenses; the representative reported that the pts underlying condition is the cause of the issues.No additional medical information was obtained and no additional medical information is expected.This event is being reported as a worst case right eye event as the diagnosis was unable to be verified by the pts treating ecp.The event date is unknown.The acuvue brand was unknown.The lot number and the suspect lens were not available.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 - USA; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7097789
• MDR Text Key: 94196408
• Report Number: 1057985-2017-00141
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/15/2017

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: 11/15/2017
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention