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

Model Number 8065993248

Device Problem Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

A customer reported that a knife doesn't cut, it doesn't have a cutting edge.There was no procedure or patient involvement.Additional information was requested.

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.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 manufacturing.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.Additional information was requested.(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: 4021221
• MDR Text Key: 4710505
• Report Number: 2523835-2014-00107
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 8065993248
• Device Catalogue Number: 8065993248
• Device Lot Number: 887963M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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