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 Ulcer (1796); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On 08sep2020 a patient (pt) in (b)(6) reported discomfort and irritation while wearing the acuvue® oasys® brand contact lenses.The pt advised the lenses last less than a month.The pts eye care provider (ecp) advised the pt to stop using lenses for more than two weeks.The pt went back to the ecp in 2 weeks and returned to contact lens wear.On 09sep2020 the pt provided additional information.The pt reported discomfort, itching sensation and blurry vision immediately on insertion of the suspect lens.The pt also noted white spots and a ¿kind of film on the lenses.¿ the pt went to an ecp who diagnosed an os corneal ulcer and advised the pt to discontinue contact lens wear for two weeks.The pt was prescribed eye drops, but couldn¿t recall the name of the eye drops.The pt reported returning to contact lens wear and the pt¿s eyes are fine.On 10sep2020 additional information was provided.The pt¿s treating ecp provided the visit note dated (b)(6) 2020.The pt presented with od pain and blurry vision for 2 days.The pt was diagnosed with infiltrated upper temporal ulcer without anterior chamber reaction.The pt was prescribed vigadexa and advised to return if needed.On 10sep2020 a call was placed to the pts treating ecp and a representative advised no frequency was noted on the pts chart for the vigadexa.The pt had a follow-up visit on (b)(6) 2020, but no additional information was noted.On 14sep2020 additional information was received from the pt.The pt confirmed the corneal ulcer was on the od and symptoms of red eye, burning sensation, tearing, and ¿difficulty seeing¿ with the first pair of lens wear (date unknown) with worsening symptoms by the third pair.The pt reported the vigadexa was prescribed every hour until bedtime on the first day, then tid for 7 days.The pt reported the od was better by the third day after beginning medication.The pt returned to the ecp on (b)(6) 2020 for a follow-up visit and the od was better.The ecp advised the pt to discontinue contact lens use for 30 days.The pt was also prescribed lubricating eye drops (name was not provided) with no additional ecp visits.The pt has a 2-month replacement schedule with daily wear.The event date is (b)(6) 2020.The lot number is unknown.The od suspect lens was discarded by the pt.No additional investigation can be conducted.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: 10567551
• MDR Text Key: 207985129
• Report Number: 1057985-2020-00050
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2020

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: PH
• Device Lot Number: UNK-PH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41