MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92002040

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

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Unspecified Infection (1930); Pain (1994); Pain (1994); Ulcer (2274)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported lot number 31369413.There is no return sample received from complainant during the report is being made, therefore no product evaluation can be performed.As no product has been returned, the investigation was solely based on a review of the manufacturing records for lot 31369413.The manufacturing investigation through device history record review of lot 31369413 has been conducted.This lot has gone through all manufacturing process stages as required by the procedures.There was no nonconformity related to the nature of complaint occurred during the manufacturing process.All in-process inspection records and final product inspection record confirmed to be within specifications.The dry lens fa # (b)(4) was assigned to lot 31369413 and confirmed met the molding process specifications.This lot has gone through 100% wet visual cosmetic inspection following standard operating procedures.The aql sampling taken for visual cosmetic quality at qc online primary packaging inspection, qc mantis sampling inspection and final cosmetic sampling inspection at qc pai were confirmed to meet the acceptance criteria.The lot 31369413 was processed at primary packaging machine # (b)(4).The sampling taken for package integrity during primary packaging process, qc mantis sampling inspection, and qc post autoclave inspection were within the specifications.The batch record of saline packaging solution # (b)(4) that used for this lot has been reviewed and met the specification.The sterilization process parameter and bi incubation result also met specifications.Infectious corneal ulcer is often referred to as ¿microbial keratitis¿ or ¿infectious keratitis¿.This case causes by a microbial agent i.E.Bacterial, viral, fungal, or amoeba.The manufacturing site has inspected the product retain samples of lot 31369413 to ensure whether there is any possibility of product contamination, therefore package integrity inspection of retain samples was performed by visually inspection and vacuum testing to ensure there are no leaks or other package integrity defects that could lead to contaminate product.12 retain samples inspected showed to meet specifications, no package integrity defect found.The complaint data and trend related to ¿h-infection - not otherwise specified (moderate); h-eye pain; h-corneal ulcer infectious¿ for lotrafilcon a product has been reviewed and did not indicate any adverse trend, overall data metrics are within the control limit.Tracking in complaint database, there was no other similar complaint reported to this lot.Based on the investigation, this lot has passed through all manufacturing process as required by the procedures.The lot was confirmed to meet all in-process and finished product specifications at the time of release.This complaint can be considered as an isolated case as there is no other similar complaint reported to this lot.No root cause can be determined.There is no impact to the other product and no field action assessment (faa) is required.No corrective action preventive action (capa) will be initiated for this complaint.Continuous monitoring of these types of events through trending and analysis may indicate future action.(b)(4).

Event Description

It was reported by an eye care professional (ecp) that a patient was seen on (b)(6) 2019 for a routine eye examination and the patient was asymptomatic at the time of visit.The patient was seen by an ophthalmologist following the routine eye examination and was diagnosed with an eye infection.The date of medical intervention as well as eye involved was unknown.The patient was then referred to a healthcare facility.Additional information was received on (b)(6) 2019 via a telephone call from the office of the ecp.It was reported that the patient visited on (b)(6) 2019 after contact lens fitting on (b)(6) 2019.It was noted that the patient was a competitive swimmer.The patient woke up in pain and changed out the original contact lens.The patient placed the second lens in his eye and continued to have pain which quickly progressed.The patient was then referred to a healthcare facility.On (b)(6) 2019, it was mentioned that the patient was getting better.On (b)(6) 2019, the patient was diagnosed with ulcer of the right eye (od) and was prescribed with moxifloxacin, treatment modality unknown.The patient was scheduled for a follow up visit on (b)(6) 2019.Additional information has been requested but not yet received.

Manufacturer Narrative

H.6.: patient code 3191 (labeled) - epithelial loss, photophobia, descemet's folds in the anterior chamber.H.3., h.6.: five (5) lenses in sealed blisters were returned.All samples were visually inspected and two were further tested.Testing was performed in accordance with the company operating procedures.The two tested samples, were found to meet manufacturing specifications for package integrity, osmolality, and ph parameters, the solution was found to be clear and in specifications.Samples were also in specification for surface and edge visual criteria, as well as, base curve and diameter parameters.However, in quality summary (qs) (b)(4), the sample 1 was found to be consistent with lot 31369413 based on the engraving ciba z448.Based on the verification result, the two tested samples, were found to meet manufacturing specifications.Samples were also in specification for surface and edge visual criteria, as well as, base curve and diameter parameters.However, in qs (b)(4), the sample 1 was found to be consistent with lot 31369413 based on the engraving ciba z448 and the sample was found to meet manufacturing specifications.

Event Description

Additional information was received on 09jan2020 via email from the eye care professional's (ecp) office.It was reported that the patient was still on prednisolone and moxifloxacin four times daily and was on limited daily contact lens wear and verified that the initial treatment was aggressive.It was noted that the location of the ulcer was superior or superotemporal, with one millimeter (mm) round epithelial defect with 3.5 mm surrounding ring infiltrate, 3+ cell, 1+ flare present and 2+ injection.The patient also experienced rapid onset pain, photophobia, excessive tearing, severe redness and decreased vision.The ecp agreed that the corneal infiltrate cannot be distinguished from microbial keratitis (likely bacterial keratitis) based on the responses to aggressive moxifloxacin treatment.The ecp mentioned that the infiltrate decreased in size at subsequent visits.Additional information was received via emailed medical records.It was reported that the patient visited the ophthalmologist on (b)(6) 2019 with a complaint of moderate pain and redness on the right eye for a day.The patient woke up a day prior with a pain scale of 10/10, visited an optometrist and was given new contact lenses that day.The patient complained of mild blurred vision in the od, did not wore contact lens in the od, but wore one in the os.The patient stated that the eye felt a little better when wearing contact lenses.The patient had used artificial tears two to three times a day.It was noted that the patient had been wearing contact lenses for about four to five years and wore the complaint contact lenses for about a month straight.Slit lamp examination revealed 2+ injection on the conjunctiva/sclera, < 1 mm round epithelial defect with 3.5 mm surrounding haze on the cornea od and 3+ cell, 1+ flare, triangle of haze on endothelium on the anterior chamber od.The patient was diagnosed with ulcer of right cornea and myopia of both eyes.The patient was started on cyclopentolate twice a day and moxifloxacin 0.5% ophthalmic drops, one drop to be instilled into the od every hour for seven days, not to wear contact lens and the patient needed eyeglasses.The patient was scheduled for a follow up visit a day after for undilated follow up.On (b)(6) 2019 the patient visited the ophthalmologist for a follow up on the corneal ulcer od.It was noted that the patient was compliant with the moxifloxacin treatment.The patient stated that the pain and redness od have slowly improved but visual acuity was still blurry.The patient added that he has not worn contact lenses since a day prior.Slit lamp examination revealed 2+ injection in the conjunctiva/sclera od, superior ring infiltrate ~2.5 mm in diameter, possible encapsulated cyst within central ring in the cornea od, 3+ cell, 1+ flare, 1+ descemet's folds in the anterior chamber od and dilated iris od.The patient was diagnosed with ulcer of right cornea and myopia of both eyes.It was noted that the patient's eye condition was worse after starting the moxifloxacin every hour.The patient was referred to a different facility for culture and was discouraged the use of monthly contact lenses.On (b)(6) 2019 the patient visited the ophthalmologist for a follow up on the corneal ulcer od.It was reported that the patient felt a lot better, "almost back to normal" and that the visual acuity on the od had gotten much better.It was noted that the patient was complaint with eye drops.Slit lamp examination revealed superior ring infiltrate ~2.5 mm in diameter in superficial stroma fading well, central infiltrate in the cornea od.The patient was diagnosed with ulcer of right cornea and myopia of both eyes.It was mentioned that the patient's eye condition significantly improved with the every hour for 72 hours moxifloxacin treatment and was currently on moxifloxacin every two hours and prednisolone twice daily.It was noted that given the significant improvement and residual haze, the prednisolone was increased to four times a day and the moxifloxacin decreased to every three hours for six days.The patient was discouraged the use of monthly contact lenses.The patient was scheduled for a follow up visit a day after for undilated follow up.Additional information received via email on (b)(6) 202 confirmed that the patient was cleared for contact lens wear.

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• MDR Report Key: 9537118
• MDR Text Key: 189201429
• Report Number: 9681121-2019-00020
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 01/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CBV92002040
• Device Lot Number: 31369413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 19 YR