MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC PACKER/CHANG IOL CUTTER; OPHTHALMIC SCISSOR

Model Number DFH-0012

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned with visable corrosion, rust and piting on the external and internal components of the scissor indicating that it had not been maintained properly which resulted in the blade breakage.

Event Description

While using a packerchang iol cutter to cut a toric iol the blade broke off in the patient's eye.There was no impact to the patient and the broken piece was removed from the eye.

• Brand Name: PACKER/CHANG IOL CUTTER
• Type of Device: OPHTHALMIC SCISSOR
• 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: robert may ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 5258322
• MDR Text Key: 32754139
• Report Number: 3019924-2015-00036
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 035977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR