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

Catalog Number	8065921541
Medical Device Problem Codes	Unsealed Device Packaging (1444); Positioning Problem (3009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 nurse reported that before surgery, an ophthalmic blade was found with the protective foam covering the tip was not proper in place.The blade scratched the nurse, and there was no issue.Surgery was performed with an alternative knife.
Additional Manufacturer Narrative
Corrected information is provided in section h.6.Additional information is provided in section h.6 and h.11.A sample was not received at the manufacturing site for evaluation for the report of blade was not properly covering the blade tip; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 20275118
• Report Number: 2523835-2024-02134
• Device Sequence Number: 12617223
• Product Code: HNN
• UDI-Device Identifier: 00380659215414
• UDI-Public: 00380659215414
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065921541
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/21/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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