MAUDE Adverse Event Report: MENICON B.V. ACUVUE ABILITI¿ OVERNIGHT; LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT

Lot Number	23346047L1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Corneal Scar (1793); Corneal Infiltrates (2231); Eye Pain (4467); Photophobia (4801); Eye Irritation (4803)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Importer's information: establishment name: (b)(6), importer sent report to fda, submission date: mar 10, 2025, importer report number: 1057985 - 2025 - 0000025.
Event or Problem Description
On 27feb2025, johnson and johnson vision care (jjvc) employee sent an email to the acuvue abiliti¿ overnight brand contact lens (cl) manufacturing site (menicon b.V.) informing them of the following adverse event.Menicon b.V.Recorded it as complaint id: (b)(4) and informed the manufacturer (menicon co.).Adverse event information: on 13feb2025, an email sent by a johnson and johnson employee advised a patient (pt) was diagnosed with a "possible corneal infection" with a resulting scar that does not impact the visual acuity (va) while wearing an acuvue abiliti¿ overnight brand cl.On (b)(6) 2025, additional information was received.The treating eye care professional (ecp) reported the pt expressed symptoms of "uncomfortable and irritated" while wearing the left eye (os) cl on (b)(6) 2024.The pt was seen on (b)(6) 2024 with findings of central corneal edema and light sensitivity.The pt was prescribed lotemax four times daily (qid).The pt was seen by the ecp for additional follow-up (fu) visits on (b)(6) 2024.The ecp reports that the pt was also seen on (b)(6) 2025 and is 20/20 with ou correction.On 28feb2025, we obtained additional information from jjvc.The treating ecp reported the pt had what looked like a "corneal infiltrate, not infective, and not corneal infection the os, that resolved with lotemax qid in 1 week." the ecp stated that it looked like a "typical infiltrate" seen in pt's using soft contact lenses.The ecp advised it may be "due to hypoxia" and "not corneal infection or bacteria as the pt was not treated with antibiotics and resolved using only steroids." the pt was left with a central mild scar, not affecting the va.The pt completed all fu and all issues resolved.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE ABILITI¿ OVERNIGHT
• Common Device Name: LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT
• Manufacturer (Section D): MENICON B.V.; waanderweg 6; emmen, drenthe 7812 HZ; NL 7812 HZ
• Manufacturer (Section G): MENICON B.V.; waanderweg 6; 7812 hz; emmen, 7812H Z; NL 7812HZ
• Manufacturer Contact: mai furutani ; 21-19 aoi 3; naka-ku; nagoya, 460-0-006 ; JA 460-0006
• MDR Report Key: 21639997
• Report Number: 1000188353-2025-00005
• Device Sequence Number: 6791544
• Product Code: NUU
• UDI-Device Identifier: 00192538951357
• UDI-Public: 00192538951357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2024
• Device Lot Number: 23346047L1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SIMPLUS SOLUTION.
• Outcome Attributed to Adverse Event: Other; Disability; Required Intervention
• Patient Sex: Female