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

Catalog Number CYP

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 09may2019 an email was received from a johnson and johnson employee who received notification that an eye care provider (ecp) in (b)(6) had a patient (pt) diagnosed with pseudomonas while wearing an acuvue oasys for astigmatism brand contact lens.On 09may2019 a call was placed to the ecps office and additional medical information was provided.The ecp reported the pt developed 2 corneal abscesses in only one eye.It was unknown which was the affected eye.The ecp spoke with the pts parent who refused to be contacted by johnson and johnson.The pt went to an ophthalmologist (name and contact information were unknown) who prescribed the pt 4 types of antibiotics (name and frequency were unknown).The pt has a follow-up appointment in 15 days.The suspect lens was taken to a lab who performed a ¿microbiology culture test¿ on the lens and the solution, ¿both in the same case¿ with results positive for ¿pseudomonas aeruginosa (blee+)¿.The ecp will place a follow-up call to the parent next week and try to obtain additional information.On 16may2019 a phone call was placed to the ecp and additional information was provided.The ecp reported speaking with the pts parent briefly.The ecp emailed questions to the parent.No return email has been received.On 22may2019 a follow-up call was placed to the ecp who reported no additional medical or product information have been received.The ecp will call to provide any additional medical or product information if it is received.The date of the event is unknown.The lot number is unknown.It is also unknown if the suspect product is available for return for evaluation.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM
• 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: 8659211
• MDR Text Key: 146680476
• Report Number: 1057985-2019-00048
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: UNK-CYP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• 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