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

Catalog Number 8065993048

Device Problems Bent (1059); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

A sample has been received by manufacturing that has not yet been evaluated.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.Additional information has been requested and confirmed to be unavailable.(b)(4).

Event Description

A nurse reported that two knives did not cut well and were noted to be bent upwards during cataract surgery.A third knife was obtained in order to successfully complete the procedure with no patient impact.Additional information was confirmed to be unavailable.

Manufacturer Narrative

Additional information is provided.Two opened knife samples were received in tip protector trays for the report of the knife edge is bent.The returned samples were visually inspected and sample number one was found to be conforming while sample number two was found to be nonconforming with a damaged cutting edge.Sample number one was then tested functionally for penetration and was found to be conforming.Since penetration testing is a destructive test, sharpness testing could not be performed.Penetration testing could not be performed on sample number two due to the damaged condition of the sample.A review of the device history record related to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates that there are three additional complaints associated with the lot for the reported issue.One sample was visually and functionally conforming and one sample was nonconforming.The exact root cause for the nonconforming sample could not be determined from the investigation performed.The damage to the returned nonconforming sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when the product is improperly removed or inserted after use, from improper handling or from contact with another instrument during surgery or set-up.The exact root cause for the damaged knife sample is unknown therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged cutting edge exhibited on the returned opened sample, is removed from the lot and scrapped.Functional penetration testing is performed and monitored during the finishing process to ensure the sharpness of the product.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• 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: 7299851
• MDR Text Key: 101254699
• Report Number: 2523835-2018-00088
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 8065993048
• Device Lot Number: 167183M
• Other Device ID Number: 380659930485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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