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

Catalog Number	8065982865
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample has been received at 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that multiple knives were blunt during separate cataract surgeries.There was no report of any patient harm.The additional information has been requested.Additional information has been received that confirmed that an alternate knife was obtained in order to complete each surgery.It was further confirmed that there was no harm to any patient.
Additional Manufacturer Narrative
A sample has been received, at the manufacturing site.That has not yet been evaluated.A review of the device history record (dhr) traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The photos attached to the parent complaint were reviewed by the manufacturing site.The photos are of four ophthalmic knife tyveks.The reported product and lot information could not be confirmed.The dhr review of the lot number 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.The exact root cause for this complaint 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.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Three opened knives in blisters and one of the knives is seated tip down in the blade protector (bp) tray was received for the report of there are new dull blades.The returned samples were visually inspected, two samples were found non-conforming with a damaged tip and damaged cutting edge and one sample was deemed conforming.Penetration testing could not be performed due to the damage to the samples and due to the tip of the blade was damaged while removing the handle.The exact root cause could not be determined from the investigation performed.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull blade.One sample was found to be visually conforming, however due to damaged to the blade during testing the blunt knife as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The exact root cause for the conforming knife was due to handling during penetration testing and for the returned damaged knife samples 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 tips and cutting edge exhibited on the returned opened samples, 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.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12240852
• Report Number: 2523835-2021-00266
• Device Sequence Number: 3531557
• Product Code: HNN
• UDI-Device Identifier: 00380659828652
• UDI-Public: 00380659828652
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 8065982865
• Device Lot Number: 315960M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 11/12/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/20/2021; 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown