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

Catalog Number	8065993047
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/05/2022
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
Physician reported that during an intra ocular implantation (iol) procedure, debris on the knives fell into the anterior chamber of the eye during the incision and it was hard to remove.The surgery was completed successfully.There was no patient harm reported.
Event or Problem Description
Additional information received.Indicated that, the debris was removed from eye.
Additional Manufacturer Narrative
Upon further review of the available information, this report of an debris on the knives fell in eye, removed from the eye, does not meet criteria for reporting, based on applicable medical device regulations.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: 15155971
• Report Number: 2523835-2022-00279
• Device Sequence Number: 5234529
• Product Code: HNN
• UDI-Device Identifier: 00380659930478
• UDI-Public: 00380659930478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 09/07/2022

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 8065993047
• Device Lot Number: 13PWK8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown