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

Catalog Number TSP

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

Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Corneal Stromal Edema (1824); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 23oct2019, a patient¿s (pt) family member called to report a diagnosis of ¿bacterial infection¿ in the left eye (os) while wearing an acuvue oasys®1 day with hydraluxe¿ technology brand contact lens (cl).No further information was available.On 11nov2019, the pts treating eye care provider (ecp) was contacted, and additional information was provided by a representative: the pt visited an urgent care (unspecified date) and was diagnosed with a corneal ulcer and prescribed moxifloxacin q3hrs for one day.The pt then visited the treating ecp on (b)(6) 2018 and was diagnosed with ¿a central corneal ulcer in os, infiltrates not infectious, corneal edema, stromal edema.¿ the treating ecp advised the pt to stop using moxifloxacin and prescribed prednisolone, 1 drop qid for 7 days.The pt had a follow up visit and on (b)(6) 2018, where the pt was cleared to returned to cl wear.The ecp representative reported that the clinical record showed a corneal scar in os central that was affecting vision at the time, ¿os 20/20 start end 20/25/ -3,¿ and that the pt ¿had some loss of visual acuity.¿ date of note, (b)(6) 2018.No additional clinical information was noted in the record.No additional information has been received.The suspect os cl is not available for return.No product or lot information was available.No analysis could be conducted.If any further relevant information is received, a supplemental report will be filed.

• 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: 9337450
• MDR Text Key: 185034929
• Report Number: 1057985-2019-00125
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2019

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: TSP
• Device Lot Number: UNK-TSP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/18/2019
• 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