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

Catalog Number	8065993047
Medical Device Problem Codes	Packaging Problem (3007); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
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 customer reported that an ophthalmic cutting knife was came out from the pack and it has a blood stains on it due technician poking.The details of procedure and patient harm was not provided.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; however, the attached customer photo confirms the reported issue of blade wrapped in a custom pak.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 attached customer photo confirms the blade poking through the tyvek.Because a sample was not returned and the blister side of the packaging can not be seen in the attached photos a root cause can not be determined; however, a manufacturing related root cause could not be ruled out.A non-conformance investigation has been initiated in order to determine the root cause for the blade through tyvek.All packages are 100% scanned by trained operators.Any non-conforming packages identified are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic cutting knife was came out from the pack and it has a blood stains on it from poking technician.The details of procedure.The technician was recovered at this time.
Additional Manufacturer Narrative
Additional information provided in section d.4.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 ; 8007579780
• MDR Report Key: 19422532
• Report Number: 2523835-2024-01155
• Device Sequence Number: 8336662
• Product Code: HNN
• UDI-Device Identifier: 00380659930478
• UDI-Public: (01)00380659930478(17)280831(11)230926(10)167R2X
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 8065993047
• Device Lot Number: 167R2X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/15/2024; 10/09/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 10/09/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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