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

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 26jun2017 our affiliate in the (b)(4) received a call from a patient (pt) who reported a current issue with an acuvue brand contact lens.During that call, the pt reported ¿a scar on her left eye that is not due to our cl but to a ulcer surgery that she had years ago¿.On 27jun2017 a follow-up call was placed to the pt and the following medical information was provided: pt reported the ¿ulcer¿ healed with medication and the pt did not have a surgery; pt can not recall if he/she was wearing an acuvue brand contact lens at the time of the event, but reported that the ¿ulcer¿ was around 2010.The pt provided the eye care provider's (ecp) contact information.On 29jun2017 a call was placed to the pts eye care provider (ecp) with the additional information provided: the ecp was unable to provide any additional medical information due to pt privacy.On 11aug2017 a call was placed to the pts prescribing ecp after receiving the pts signed consent to release medical information.The ecp reported the pt was wearing acuvue advance brand product in 2009.On (b)(6) 2010, the pt was placed in acuvue oasys brand product which the pt was wearing when he/she left the practice in 2012.The pts medical records were requested from the ecp to confirm which acuvue product the pt was wearing at the time of the corneal ulcer diagnosis, additional medical information, and date of the event.On 05sep2017 our affiliate in the (b)(4) reported that multiple attempts have been made to the ecp for additional medical information, but no additional medical information has been received.The os corneal ulcer and scar are being reported as a worst-case event as the diagnosis and treatment have not been verified by the pts ecp.It is unknown which acuvue brand product the pt was wearing at the time of the event; the lot # is unknown and no product is available for return.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 05sep2017, the eye care provider (ecp) sent the patient (pt¿s) medical records by email to our affiliate in (b)(4).The following additional information was provided: two retinal photographs of the pt¿s eyes dated (b)(6) 2010.Two retinal photographs of the pt¿s eyes dated (b)(6) 2010.On (b)(6) 2010 ¿ optometrist note: acuvue advance bvp, os (left) -3.25/8.3/14.0.On (b)(6) 2010: reason for visit: ulcer (l) attended rvi.Symptoms: ulcer ¿ 3 weeks ago.Cvi said healed and scar tissue.Contact lenses 1 year ago, no allergies, no hospital, distance blurred.History: illegible entries.External: lids/lashes: clear os, cornea: clear os, conjunctiva: drawing depicting corneal scar left eye, no stain.A/c: quiet os, tears left 0.1.Internal: no opacity os, lens: illegible, discs/cup: 0.2 tear os, colour/margins: defined os, vessels: 2/3, a/v ration: illegible, background: illegible, macula: clear bright reflex os, iop: 18 os, va: 6/5 os, left -3.25/-0.75/60.Advice given to pt: new distance glasses, bvp px, ok to wear lenses, post ulcer, needs 1 month aftercare.Date: (b)(6) 2010.Last exam: (b)(6) 2010.History: previous left eye ulcer.On (b)(6) 2010 - drawing of pt¿s eye depicting peripheral corneal scar.On (b)(6) 2011 -pt lens fitting.History: previous ulcer right eye.Date: on (b)(6) 2012, history: hes ¿ ulcer corneal.On 03oct2017, our affiliate in (b)(4) requested additional medical information from the ecp for clarification of the (b)(6) 2011 medical record note reporting of previous ulcer right eye.The medical records indicate the pt was wearing acuvue advance lenses at the time of the diagnosis.No additional medical information was 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 - US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6846277
• MDR Text Key: 85096045
• Report Number: 1057985-2017-00108
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 10/05/2017
• 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