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

Catalog Number AOS

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Eye Pain (4467)

Event Date 06/06/2023

Event Type  Injury  

Event Description

On 15jun2023, an eye care professional (ecp) notified johnson and johnson vision care that a patient (pt) was diagnosed with a sterile central corneal ulcer after wearing the acuvue® abiliti¿ overnight brand contact lens.The pt began wearing the lenses in the beginning of (b)(6) 2023 and ¿had a couple of follow-up visits since yesterday¿s visit.¿ the ecp did not find anything significant in the pt¿s corneas during the previous visits, but the pt did complain of mild discomfort which the ecp associated to the learning curve wearing orthokeratology (orthok) lenses for the first time.On 16jun2023, an email notification was sent to the acuvue® abiliti¿ overnight lens manufacturer (menicon) to advise of the sterile central corneal ulcer.On 20jun2023, an email acknowledgement was received from the manufacturer (menicon) advising the complaint was logged as identification number (b)(4).Attempts were made to the ecp for additional medical information, lot number and suspect product availability.On 20jun2023, additional medical information was provided by the ecp: the ecp advised as part of ¿their protocol¿, the pt was dispensed a small bottle of diluted proparacaine and artificial tears to help with the adjustment to rigid gas permeable (rgp) lenses.The pt had been using it a little more in the week leading up to the incident and reported the pt had a ¿little bit of a cold.¿ the ecp ¿wouldn¿t attribute the ulcer solely to orthok lens wear.¿ the pt was using unique ph solution at the time of the event and reported the lenses were clean and clear of deposits.The pt was reported to wearing the lenses at night between 9-10 hours.The right eye (od) refraction with the od lens on was recorded as +1.50.On 21jun2023, additional medical information by the prescribing ecp was received.The ecp reported the pt was seen on (b)(6) 2023 which is noted as the date of event.The ecp reported a finding of 0.5 mm round ulcer in the od at the time of the visit.The pt was advised to discontinue lens wear and prescribed ciloxan tid od for 1 week.No secondary complications were noted.The pt was asymptomatic on the day the od corneal ulcer was diagnosed.The pt reported onset of symptoms started on (b)(6) 2023, without worsening symptoms.The pt started wearing the acuvue® abiliti¿ overnight brand contact lens on (b)(6) 2023 and has a negative ocular history prior to start of ortho-k-tx.The normal daily wear is instructed as ¿overnight¿, and the suspect lens was worn 1-3 months.The lens case solution is replaced daily.The ecp reported the lenses were used as instructed by the ecp and does not suspect any lens misuse.The ecp reported there has been a fitting adjustment after the onset of the issue (no details were provided).The pt had been using no more than 1 drop diluted proparacaine in both eyes prior to lens insertion for 1-2 weeks leading up to the event.On 06jul2023, the ecp provided additional medical information.The ¿pt was not instructed to use the proparacaine more frequently.¿ the pt¿s family member reported that the pt used at maximum, one drop per day prior to insertion, which is in accordance with what was prescribed.On 10jul2023, the suspect product was received by johnson and johnson vision care, returned to the manufacturer and is currently in transit for evaluation.The lot number is unknown.No additional evaluation can be conducted.No additional information has been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Johnson and johnson vision care is reporting this event as the importer for acuvue® abiliti¿ overnight brand contact lens.A separate report will be submitted by the manufacturer.Reference fei number (b)(4).H3 other text : suspect device sent to manufacturer.

Manufacturer Narrative

On 17jul2023, product evaluation results for the suspect contact lenses (cls) were received from the manufacturer (menicon): lens inspection conducted on 14jul2023: "lens order number 23130979 shipment date march 29, 2023.Manufacturing record is checked, no deviations.Lens specifications bcr, power, diameter and thickness are measured and conform specifications produced.Visual inspection: ¿ front surface show small scratches in central area.¿ back surface show small scratches in central area.¿ edges, no deviations.¿ fenestrations, no deviations.The scratches on the front and back surface are normal for regular use of the products.Conclusion: the lens meets specifications and shows no deviations that could cause the complaint described (sterile central corneal ulcer)." on 18jul2023, additional information was provided by the manufacturer (menicon).¿ lot number: 23130979.¿ manufacturing date 28th march 2023.¿ expiration date 28th march 2025.The manufacturer (menicon) reported the event to the fda on 14jul2023 (reference mfr report #(b)(4)).On 26jul2023, additional information was provided by the patient's (pt's)treating eye care professional (ecp).The corneal ulcer has resolved with little scarring and the pt has returned to cl wear.Johnson and johnson vision care is reporting this follow-up report as the importer for acuvue® abiliti¿ overnight brand contact lens.A separate report will be submitted by the manufacturer.Reference fei number (b)(4).

• Brand Name: ACUVUE® ABILITI¿ OVERNIGHT
• Type of Device: 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; emmen, drenthe 7812 HZ; NL 7812 HZ
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256
• MDR Report Key: 17321171
• MDR Text Key: 319099367
• Report Number: 1057985-2023-00045
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

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: AOS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2023
• Distributor Facility Aware Date: 06/15/2023
• Date Report to Manufacturer: 08/03/2023
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DILUTED PROPARACAINE, ARTIFICIAL TEARS, UNIQUE PH.
• Patient Outcome(s): Other; Required Intervention