MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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

Patient Problems Corneal Edema (1791); Inflammation (1932); Neovascularization (1978); Discomfort (2330)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 29oct2019 an email was received from the fda, mw5090302 with information received from an eye care provider (ecp) who reported a new patient (pt) presented with significant corneal and conjunctival inflammation, discomfort and reduced vision on (b)(6) 2019 while wearing an acuvue® oasys® brand contact lens.The pt was ¿over-wearing and misusing¿ the contact lenses and had not had an eye exam or contact lens evaluation in more than 10 years.The pts prior prescribing ecp retired 5 years ago and the office was closed.The pt continued to receive contact lenses from an on-line provider without a valid prescription or prescription verification from the on-line provider.The emergent office visit revealed corneal edema, corneal staining and corneal neovascularization.No additional medical information was provided.The lot number of the suspect product was not provided.Multiple attempts were made to the reporting ecp for additional medical and product information, but nothing additional has been provided.It is unknown if the suspect lens is available for return for evaluation.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9324649
• MDR Text Key: 185033798
• Report Number: 1057985-2019-00123
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention