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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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 nurse reported that during phacoemulsification and intraocular lens implantation surgery, an ophthalmic knife tip detached when opened for incision.There was no patient contact and the surgery was completed with an alternative knife.
Additional Manufacturer Narrative
Additional information is provided in sections d.4, h.6 and h.11.A sample was not received at the manufacturing site for evaluation for the report of tip of the knife detaches when opened for incision; however, photo attached to parent file confirm the reported issue.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 report of tip of knife detached is confirmed based on the photo attached to parent complaint.However; because a sample was not received at the manufacturing site and no lot information was provided, 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.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, e.1, h.3, h.6 and h.11.One opened knife, in a protector tray, in a bag with was received for the report of tip of the knife detaches when opened for incision.Sample was visually inspected and found to be nonconforming.Blade tip was observed to be broken off.The shaft of the blade was only returned in the safety handle.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The photo attached was reviewed by the manufacturing site.Photo show a knife with tip broken off.Reported issue confirmed from photo.The returned sample is visually non-conforming with the tip of the knife broken off.How and when the knife tip broke off cannot be determined; however, a manufacturing related issue cannot be ruled out for this defect.An investigation is in progress in order to further investigate issues with blade broken off.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the broken 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).

• 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: 19077851
• Report Number: 2523835-2024-00596
• Device Sequence Number: 20481296
• Product Code: HNN
• UDI-Device Identifier: 00380657715411
• UDI-Public: (01)00380657715411(17)280831(11)230913(10)1668D6(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K110166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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: 1668D6
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 06/30/2024; 11/01/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/26/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: Unknown