MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 an eye care provider (ecp) called to provide additional information regarding a complaint received from a patient (pt) regarding a current issue with the acuvue oasys 1 day brand contact lenses.During the call, the pts ecp reported the pt was diagnosed in (b)(6) 2018 with a small corneal ulcer while wearing the acuvue oasys 1 day brand contact lenses.The ecp also reported the pt had sjogren's syndrome.On 12jun2018 a call was received from the pts treating ecp who provided additional information: pt was seen on (b)(6) 2018 with complaints of redness, discomfort and pt saw a ¿white spot¿ on the od.Pt was diagnosed with ¿suspicion of corneal ulcer in superior cornea, more peripheral¿.Pt was ¿treated as infectious vs.Sterile with gatafloxacin q 2 h until (b)(6) 2018¿.Pt was seen in the clinic the following day and diagnosed with ¿staphylococcus marginal ulcer¿ and the pt was prescribed prednisolone acetate bid.The ecp reported no culture was obtained and pt was treated with their ¿standard of care¿.The ecp reported that ¿all ulcers are treated aggressively and it is not certain if ulcer is infectious or a hypersensitivity to staph bacteria¿.The ecp reported that prednisone is typically added when they believe ¿it may be a hypersensitivity to the staph bacteria¿.The pt was seen on (b)(6) 2018 and the gatafloxacin was decreased to qid and prednisone decreased to qd; ulcer healed; no infiltrate; pts va without cl before and after the event is 20/40, no change in va.The ecp reported the pts last visit was on (b)(6) 2018 and it is unknown if the pt returned to contact lens wear.Multiple attempts were made to the pt for the suspect lot number and suspect product availability.It is unknown if the suspect product is available for return.No additional information has been received.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: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• 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: 7650800
• MDR Text Key: 112741573
• Report Number: 1057985-2018-00085
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Device Lot Number: UNK-TSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention