MAUDE Adverse Event Report: MANI, INC. MANI OPHTHALMIC KNIFE; KNIFE, OPHTHALMIC

Model Number	MSL24SH
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endophthalmitis (1835); Visual Impairment (2138); Intraocular Pressure Decreased (4468)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information about the patient was obtained from the distributor on (b)(6) 2023.On (b)(6) the patient underwent cataract surgery on her right eye.6 days after the surgery, she was aware a reduction of vision and the doctor found that she had a problem with the wound opening and a tendency toward low iop.Anterior chamber aqueous humor leakage from the wound also was confirmed.At this time, it cannot be determined that mani ophthalmic knife products are the cause of the leakage.
Additional Manufacturer Narrative
As we had received and tested of the devices from same lot returned from user, no abnormalities were found in their appearance and the penetration test.In addition we had checked our manufacturing records.As a result of that, we concluded that no abnormality has been identified.We attached our complaint handling investigation report.And the results of the above report has been explained to ophthalmologist dr.(b)(6) on (b)(6) 2023.

• Brand Name: MANI OPHTHALMIC KNIFE
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): MANI, INC.; 8-3 kiyohara industrial park; utsunomiya, tochigi 321-3 231; JA 321-3231
• Manufacturer (Section G): MANI HANOI CO. LTD; vang residential group; tan huong ward; pho yen city, thai nguyen province ; VM
• Manufacturer Contact: hiroyuki ogiwara ; 8-3 kiyohara industrial park; utsunomiya, tochigi 321-3-231 ; JA 321-3231
• MDR Report Key: 16510192
• Report Number: 3002692886-2023-00002
• Device Sequence Number: 14848096
• Product Code: HNN
• UDI-Device Identifier: 14546951404458
• UDI-Public: (01)14546951404458(11)220906(17)270806(10)K220234000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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
• Operator of Device: Other
• Device Model Number: MSL24SH
• Device Catalogue Number: MSL24SH
• Device Lot Number: K220234000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian