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

Model Number DFH-0012

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The distributor reported that the packer/chang iol scissor broke when the surgeon attempted to cut a one piece acrylic iol.There was no impact to the patient and the broken piece was removed from the eye.

Manufacturer Narrative

The scissor was returned along with the one piece hard iol (uncut) with damage that is indicative of the scissor being used to cut too hard of an object.The one piece lens was scored where the surgeon attempted to cut the lens.The surgeon reported that he was attempting to use the scissor to cut the one piece acrylic iol.This scissor is indicated to cut soft foldable iols.

• Brand Name: PACKER/CHANG IOL CUTTER
• Type of Device: OPHTHALMIC SCISSOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., n.e.; redmond, WA 98052 ; 4255560544
• MDR Report Key: 3899031
• MDR Text Key: 4648707
• Report Number: 3019924-2014-00017
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 050336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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: 80 YR