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

Lot Number 23130979

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

We are collecting information on patient outcomes.We are requesting the device be returned to us for evaluation.Importer's information establishment name : johnson and johnson vision care, inc.Address : 7500 centurion parkway, jacksonville florida 32256 telephone number : (b)(4) contact person : (b)(4) email address: : (b)(4) importer sent report to fda: submission date : jul 13, 2023 mfr report number : 1057985 - 2023 - 00045.

Event Description

On (b)(6) 2023, an eye care professional (ecp) notified our importer johnson and johnson vision care (jjvc) 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 april 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, jjvc sent an email to the acuvue abiliti¿ overnight lens manufacturer (menicon) to advise of the sterile central corneal ulcer.On 20jun2023, jjcv received an email from menicon advising that the complaint was recorded as (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 jjvc, returned to menicon 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

On 03aug2023, johnson and johnson vision care, inc., our importer of the acuvue abiliti¿ overnight, submitted the follow-up report.Mfr report number : 1057985 - 2023 - 00045.

Event Description

On 10jul2023, the suspect product was received by johnson and johnson vision care, inc., and returned to menicon for evaluation on 13jul2023.On 14jul2023, menicon conducted the evaluation.Details of the evaluation results are shown in b6.The conclusion of the evaluation was that no deviations were detected during the specification and general inspections.As a result of the cornea treatment, the patient (pt) recovered with little scarring and returned to wearing contact lenses.Proper handling and regular eye examinations are described in the instructions for patients.Unclear how the pt was guided by the eye care professional.

• 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; 7812 hz; emmen, 7812 ; NL 7812
• Manufacturer Contact: mai furutani ; 21-19 aoi 3; naka-ku; nagoya, 460-0-006 ; JA 460-0006
• MDR Report Key: 17325409
• MDR Text Key: 319045298
• Report Number: 1000188353-2023-00001
• Device Sequence Number: 1
• Product Code: NUU
• UDI-Device Identifier: 00192538951357
• UDI-Public: 00192538951357
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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 Lot Number: 23130979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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: ARTIFICIAL TEARS.; DILUTED PROPARACAINE.; UNIQUE PH.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female