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

Catalog Number	8065771540
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that during cataract surgery an ophthalmic blades were dull and on multiple occasions physician had to apply significant pressure to make the incision and to get a sharp one.Physician reported patients had epithelial defects on the cornea and it improved over time.
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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.42 unopened knives, in boxes, in protector trays, in blisters were received for the report of dull blades, epithelial defects on the cornea.As per sampling plan 13 randomly selected samples were visually inspected and found to be conforming.Functional penetration testing was then performed and found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned unopened samples were visually and functionally found to be conforming, therefore dull blades as described in the complaint was not confirmed.However since the actual complaint samples were not returned, a root cause cannot be determined for the complaint as described by the customer.The unopened samples were found conforming; however because the actual complaint samples were not returned the exact root cause for this complaint is unknown, 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.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19056523
• Report Number: 2523835-2024-00565
• Device Sequence Number: 15208626
• Product Code: HNN
• UDI-Device Identifier: 00380657715404
• UDI-Public: 00380657715404
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065771540
• Device Lot Number: 16ALPE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/06/2024
• Supplement Report FDA Received Date: 07/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown