MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE I-KNIFE II; KNIFE, OPHTHALMIC

Catalog Number 8065992762

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

A healthcare professional reported that the surgeon noted silver dust at the incision site at the end of a surgical procedure.The surgeon was unable to remove all particles.

Manufacturer Narrative

No sample has been returned for evaluation for the report of metallic shavings at incision; therefore, the condition of the product could not be verified.A review of the device history record traceable to the possible lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are two additional complaints associated with the lot for the reported issue.A sample was not returned and the device history record review of the lot numbers provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: I-KNIFE II
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6577783
• MDR Text Key: 75677118
• Report Number: 2523835-2017-00378
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065992762
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR