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 Edema (1791); Iritis (1940); Keratitis (1944); Blurred Vision (2137); Caustic/Chemical Burns (2549)

Event Date 04/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020 a representative from an eye care provider¿s (ecp) office called to report a patient (pt) had a ¿chemical burn¿ od while wearing the acuvue® oasys® brand contact lenses.The pt was seen and diagnosed on (b)(6) 2020.The pt did not report any issues with the lenses but was ¿not doing well with them and wanted to change brands.¿ the diagnosis provided by the treating ecp was ¿iritis, coded as anterior uveitis, corneal edema and spk.¿ the pt does not have any loss of va or permanent damage.The pt was prescribed ofloxacin 1 drop qid for 7 days.On the 2nd day the pt was to start prednisolone acetate ophthalmic drops 1 drop qid for 7 days.The representative reported the pt was seen today ((b)(6) 2020) and is reported to be doing better.The pt has a follow-up (fu) appointment tomorrow to evaluate the treatment provided.On 22apr2020 a return call was placed to the pts treating ecp¿s office and additional medical information was provided.The pt reported the issue was with the lens because the pt was using the same solution for the os and had no issue with the os.The treating ecp put a bandage lens in the od.The pt reported some blurry vision.No other recorded changes were noted in the pt record.The pt has a fu appointment scheduled for next friday.No other medical information was provided.On 04may2020 additional medical information was provided by the ecp¿s office.The pt was seen for a fu visit on (b)(6) 2020 and was provided artificial tears.The pt is to continue with the antibiotics and will be seen tomorrow to evaluate the blurry vision.On 05may2020 additional medical information was provided by the treating ecp¿s office.The representative reported the od blurry vision comes and goes but is getting better.The antibiotic treatment was discontinued.The pt is currently only using artificial tears.The pt has a fu appointment next monday.On 12may2020 additional medical information was provided by the ecp¿s office.The representative reported the pt is doing much better and the ecp expects a full recovery.The pt has a fu appointment for next week.No additional medical information was provided.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 b00th9f was produced under normal conditions.The suspect od contact lens was discarded.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: 10053421
• MDR Text Key: 199284297
• Report Number: 1057985-2020-00031
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• 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: B00TH9F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention