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 Irritation (1941); Keratitis (1944); Pain (1994); Burning Sensation (2146); Fungal Infection (2419)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 23 oct 2019, a patient¿s (pt) family member called to report the pt developed a ¿fungal infection in the os¿ while wearing the acuvue oasys®1 day with hydraluxe¿ brand contact lenses (cls) and can¿t return to cls wear.No issues were noted with the os suspect lens.The pt reported symptoms of pain, burning and irritation after removing the suspect lens on (b)(6) 2019.The family member reported the pt does ¿any¿ outdoor work, bathrooms and grinding concrete.The pt went to the ophthalmologist on (b)(6) 2019 and diagnosed with ¿fungal infection, filamentous fungus, dematiaceous fungi.¿ the pt was prescribed moxifloxacin 1 drop 4-6 times a day, then a week later the frequency changed to q1h since the symptoms didn¿t resolve.The pt was also prescribed cipro ointment bid, vancomycin, amphotericin eye drops (pt was in the hospital with 2 days of iv amphotericin b) and the pt is currently on voriconazole eye drops.The pt had a corneal transplant on (b)(6) 2019 and reported the os is better and the pt is gaining eyesight every day.The family member reported the pt wore the lenses daily and removed the lenses at night.On 25 oct 2019, a call was placed to the pts treating ecp and additional medical information was requested.No additional medical information was provided.On 11 nov 2019, a call was placed to the pts treating ecp and additional information was provided by a representative: the pt was diagnosed with ¿fungal infection keratitis, mucormycosis, fusarium aspergillus¿; the medication as previously provided by the pt¿s family member was verified with the addition of artificial tears prn; the pt was seen daily in the office from (b)(6) 2019.The pt was hospitalized for 2 days prior to the transplant surgery to receive iv antibiotics (not specified).The representative verified the pt had a cornea transplant on (b)(6) 2019.The pt had ¿permanent damage and permanent loss of visual acuity 20/60 in the os before surgery.¿ after surgery the os va was 20/150 and the va was checked again on (b)(6) 2019 noted as 20/100, improving.Date of note, 08 nov 2019.No additional clinical information was noted in the record.No additional medical information has been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 6314260112 was produced under normal conditions.The suspect os lens was discarded by the pt.No evaluation can 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; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32258 ; 9044433364
• MDR Report Key: 9336569
• MDR Text Key: 184533623
• Report Number: 9617710-2019-00047
• 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

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: TSP
• Device Lot Number: 6314260112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 61