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 Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a patient (pt) reported sleeping in an unknown acuvue brand contact lens one time about 4 years ago and was diagnosed with an ¿infection¿.The pt can¿t recall which was the affected eye or what acuvue brand was worn at the time of the event.The lot number and the suspect product are not available.The pt reported the event was ¿possibly a corneal ulcer¿ and was told by the doctor there is a scar on the eye.On (b)(6) 2018 a call was placed to the pt's treating eye care provider (ecp) and a representative provided additional information: -the representative reported that the pt has worn an acuvue product since 2006, but the brand has changed over the years.The representative could not find notes related to the reported event.The representative will speak with the ecp and call back with any additional information.On (b)(6) 2018 the representative from the ecp¿s office called and reported the ecp did not see the pt for scarring.No additional information was provided.Multiple attempts were made to contact the pt to verify the treating ecp contact information, but no additional information has been received from the pt.The lot number is unknown and the suspect product is not available for return.If any further relevant information is received, a supplemental report will be filed.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 ; 9044433364
• MDR Report Key: 7656451
• MDR Text Key: 112994759
• Report Number: 1057985-2018-00087
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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
• Date Manufacturer Received: 06/08/2018
• 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; Disability