MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLEARCUT S INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION); KNIFE, OPHTHALMIC

Catalog Number	8065771541
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that a female patient underwent cataract surgery on her right eye, during which the ophthalmic knife failed to make an incision.The surgery was completed on the same day using the same knife with increased force, and then switched to a new knife.The surgery proceeded without complications, and no medical or surgical intervention was necessary.However, the patient's outcome was currently unknown.
Additional Manufacturer Narrative
One opened knife, in a blister was received for the report of blunt knife.Sample was visually inspected and found to be nonconforming, blade was observed to have a bent tip.Penetration testing could not be performed due to the damage of the sample.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria the exact root cause could not be determined from the investigation performed.The damage to the returned sample 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 sample could have contributed to the customers reported issue of blunt knife.The exact root cause for the damaged knife sample is unknown, therefore specific action with regards to this complaint cannot be taken.A nonconformance investigation is currently in progress to investigate the trend identified for dull cutting instruments.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged tip 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).
Additional Manufacturer Narrative
Corrected information is provided in d.4 the manufacturer internal reference number is:(b)(4).

• Brand Name: CLEARCUT S INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION)
• 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 ; 8007579780
• MDR Report Key: 19211420
• Report Number: 2523835-2024-00777
• Device Sequence Number: 20893351
• Product Code: HNN
• UDI-Device Identifier: 00380657715411
• UDI-Public: (01)00380657715411(17)280930(11)231011(10)168NME(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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 Catalogue Number: 8065771541
• Device Lot Number: 168NME
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 09/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/14/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK.
• Patient Sex: Female