MAUDE Adverse Event Report: ALCON PRECISION DEVICE, SINKING SPRING KNIFE; MANUAL OPHTHALMIC SURGICAL INSTRUMENT

Model Number 8065982465

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

A surgeon reported that during a procedure it was noted that the tip of the knife was chipped.The knife was exchanged and surgery was completed with no harm to the pt.

Manufacturer Narrative

A sample has been received and in-house testing is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.All knives are 100% inspected by trained operators using a minimum of 10x magnification during mfg.Any defects, such as damaged tips and cutting edges, are removed from the lot and scrapped.Sharpness testing is performed and monitored during the finishing process to ensure the sharpness of the product.(b)(4).

• Brand Name: KNIFE
• Type of Device: MANUAL OPHTHALMIC SURGICAL INSTRUMENT
• Manufacturer (Section D): ALCON PRECISION DEVICE, SINKING SPRING; 714 columbia ave.; sinking spring PA 19608
• Manufacturer (Section G): ALCON PRECISION DEVICE, SINKING SPRING; 714 columbia ave.; sinking spring PA 19608
• Manufacturer Contact: janet moran ; 6201 south freeway r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4349782
• MDR Text Key: 20976719
• Report Number: 2523835-2014-00205
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 8065982465
• Device Catalogue Number: 8065982465
• Device Lot Number: 926651M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1