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

Lot Number	24427901L1
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)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Importer's information: establishment name: (b)(6); address: (b)(6); telephone number: (b)(6); contact person: (b)(6); email address: (b)(6).Importer sent report to fda: submission date: mar 10, 2025; importer report number: 1057985 - 2025 - 0000026.
Event or Problem Description
On 28feb2025, 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 26feb2025, additional information was received.The treating eye care professional (ecp) reported the pt was in the office on (b)(6) 2025, asymptomatic, and was prescribed lotemax four times daily (qid).The pt was seen by the ecp for additional follow-up (fu) visits on (b)(6) 2025 and (b)(6) 2025 with "slow improvements of edema".On 28feb2025, additional information was provided: the treating ecp reported that the pt experienced a "corneal infiltrate like an immune response with white cells, but not infectious as pt was treated with lotemax qid for 1 week and never used antibiotics to treat the pt." the pt resulted with a minor central corneal scar, not affecting the va.The pt had a follow-up (fu) visit last week and completed the treatment with all symptoms resolved.The ecp advised that "the pt is young and should be fine and able to continue to use lenses." the suspect product was received by jjvc, returned to menicon b.V.For evaluation and is currently in transit.If any further relevant information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
Importer's information: establishment name : johnson and johnson vision care, inc.Address : (b)(6).Telephone number : (b)(6).Contact person : (b)(6).Email address: globalmedical@its.Jnj.Com.Importer sent report to fda.Submission date : mar 10, 2025.Importer report number : 1057985 - 2025 - 0000026.
Event or Problem Description
On 28feb2025, 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)(6) 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 26feb2025, additional information was received.The treating eye care professional (ecp) reported the pt was in the office on (b)(6) 2025, asymptomatic, and was prescribed lotemax four times daily (qid).The pt was seen by the ecp for additional follow-up (fu) visits on (b)(6) 2025 and (b)(6) 2025 with "slow improvements of edema".On 28feb2025, additional information was provided.The treating ecp reported that the pt experienced a "corneal infiltrate like an immune response with white cells, but not infectious as pt was treated with lotemax qid for 1 week and never used antibiotics to treat the pt." the pt resulted with a minor central corneal scar, not affecting the va.The pt had a follow-up (fu) visit last week and completed the treatment with all symptoms resolved.The ecp advised that "the pt is young and should be fine and able to continue to use lenses." the suspect product was received by jjvc, returned to menicon b.V.For evaluation and is currently in transit.If any further relevant information is received, a supplemental report will be filed.
Event or Problem Description
Menicon conducted the investigation of the lenses returned by the patient.Details of the investigation results are shown in b6.The conclusion of the investigation was that no abnormalities were found.In the initial report, we reported that the patient was treated with a mild scar that did not affect the va.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: 21639991
• Report Number: 1000188353-2025-00006
• Device Sequence Number: 6791543
• 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,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 11/13/2025
• Device Lot Number: 24427901L1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 02/28/2025; Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/02/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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; BOSTON SIMPLUS SOLUTION
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Sex: Female