MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS FOR ASTIGMATISM; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number CYP

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

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Keratitis (1944); Pain (1994); Corneal Infiltrates (2231); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On 31jul2020, a distributor in (b)(6) reported a patient (pt) experienced discomfort in both eyes in (b)(6) 2020 on the first day of wearing acuvue® oasys® for astigmatism brand contact lenses.No further information was received.On 06aug2020, the pt was contacted and provided additional information: the pt reported having ¿a white spot and signs of infection¿ in the right eye (od).The pt sought medical attention and was prescribed: milflox, toba, vancomycin tolpa d (used every hour for a month) and nevanac, homide (3 times a day).The od is currently resolved.The pt reported the event date was (b)(6) 2020.The pt will provide the medical report.On 13aug2020, the medical report was received from the pt: date of visit: (b)(6) 2020; exam findings: od ¿ mild eyelid edema, conjunctival congestion, 2 mm cornea ulcer with infiltrate, anterior chamber with 2+ cells; diagnosis: od microbial keratitis; prescriptions: milflox eye drops (moxifloxacin hydrochloride 0.5%) od every hour until sleep for 15 days, homide eye drops (homatropine hydrobromide e/d ip) od 3 times a day for 15 days, vancomycin eye drops od 1 drop every hour until sleep for 15 days, tolpa-d tablets (diclofenac sodium and serratiopeptidase) 2 times a day for 3 days; pt was advised to return after 2 days.No additional information has been received.The suspect od contact lens was requested for return for evaluation but has not yet 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 b00tfm4 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One lens case containing 1 lens was received for lot b00tfm4.The parameters of the lens were measured and a visual inspection was performed.The lens met company standards for base curve, center thickness, and diameter.No visual attributes were observed.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 10456235
• MDR Text Key: 204568989
• Report Number: 1057985-2020-00043
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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: CYP
• Device Lot Number: B00TFM4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 YR