MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. 19G PACKER CHANG IOL CUTTERS; OPHTHALMIC SCISSORS

Model Number	DFH-0012
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
Scissor tips don't fully close, so the surgeon had to cut the iol more towards the base of the scissors.Because of this, the tips were further extended within the anterior chamber, and they made contact with/ruptured the capsular bag, which prompted the need for an additional procedure.
Additional Manufacturer Narrative
The device was originally manufactured in 2017 which is 3 years past its life expectancy.The scissor showed signs of normal wear and tear.

• Brand Name: 19G PACKER CHANG IOL CUTTERS
• Common Device Name: OPHTHALMIC SCISSORS
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 19102234
• Report Number: 3019924-2024-00002
• Device Sequence Number: 7705573
• Product Code: HNF
• UDI-Device Identifier: 00844685001323
• UDI-Public: 00844685001323
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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: Health Professional
• Device Expiration Date: 04/17/2017
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 087715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown