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

Catalog Number	8065992747
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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 health professional reported that a knife was noted to be dull during a cataract procedure.An alternate knife was obtained in order to complete the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
One opened angled ophthalmic slit knife in a blister was received.The returned sample was visually inspected and was found non-conforming with a damaged tip.Penetration testing could not be performed due to the damage of the sample.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 photos attached to the parent complaint were reviewed by the manufacturing site.The photos are of a knife blade and a knife high-density polyethylene fibers (hdpe) label, the reported product complaint could not be confirmed and the product and lot information is confirmed.The exact root cause could not be determined from the investigation performed.The damage to the returned sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint sample could have contributed.The exact root cause for the damaged knife sample 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.Any nonconformance, such as the damaged 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.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 12515911
• Report Number: 2523835-2021-00359
• Device Sequence Number: 3687198
• Product Code: HNN
• UDI-Device Identifier: 00380659927478
• UDI-Public: 00380659927478
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 02/28/2026
• Device Catalogue Number: 8065992747
• Device Lot Number: 13U9VV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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 Age: 68 YR
• Patient Sex: Female