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

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Eye Injury (1845); Foreign Body Sensation in Eye (1869); Acanthameba Keratitis (1945); Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021 a patient (pt) in (b)(6) reported years ago while wearing an unknown acuvue brand contact lens (cls) the suspect od cls tore during wear and ended up scratching the eye.The pt also felt something on the eye.The pt went to an eye care provider (ecp) in (b)(6) 2014 who diagnosed the pt with acanthamoeba.The treating ecp name, contact information and medication prescribed at the time were unknown at the time of the call.The pt stated the scratched eye ended up with a fissure on the od.The pt reported daily cls wear, with a 15 to 30-day replacement schedule.On (b)(6) 2021 a call was placed to the pt who provided additional information.The pt reported at the beginning of 2013 or 2014, while wearing the suspect od lens at the beach, the pt itched the eye causing a small scratch.The pt visited the hospital and the ecp thought the pt had conjunctivitis.The ecp provided unknown treatment at that time.The symptoms didnt improve, so the pt returned to the ecp.The ecp then thought it was an allergic reaction and additional unknown medication was prescribed.The symptoms didnt improve and after 3 months from the initial treatment, the pt was referred to a cornea specialist.The specialist performed a biopsy of the eye discharge, which was negative.The cornea specialist ordered a deeper biopsy which was positive for acanthamoeba.The ecp advised the pt probably had a very small cut on the cornea which allowed bacteria to enter.The pt was treated with medications for several months and did not wear cls for a year.The pt advised the od was ok after the treatment, but the od had scarring.The pt reported daily cls wear with a 1-year replacement schedule.The pt used renu for astigmatism lenses solution to clean the lenses.The pt is unable to provide which toric acuvue brand cls was worn at the time of the event.The pt advised the event occurred long ago so no additional information regarding the event is available.Multiple calls were placed to the pts treating eye care provider, but no additional medical information was provided.No additional medical information has been received.This event is being reported as a worst-case event as we were unable to verify the diagnosis and treatment with the treating ecp.The suspect lot number was discarded.The suspect od cls was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11790131
• MDR Text Key: 262202703
• Report Number: 1057985-2021-00127
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention