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

Catalog Number	8065990002
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample has been received at manufacturing for evaluation.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 multiple knives were blunt during separate cataract surgeries.There was no report of any patient harm.The additional information has been requested.Additional information has been received that confirmed that an alternate knife was obtained in order to complete each surgery.It was further confirmed that there was no harm to any patient.
Additional Manufacturer Narrative
A sample has been received at the manufacturing site that has not yet been evaluated.A review of the device history record (dhr) 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 four ophthalmic knife tyveks, the reported product and lot information could not be confirmed.The dhr review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint 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.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened knife in a blister was received for evaluation.The returned sample was visually inspected and was found conforming.The sample was then functionally tested for sharpness testing and was found non-conforming.Upon further visual inspection, after sharpness testing was performed, the returned knife was noted to have side cutting edges that were conforming and a radius cutting edge that was unacceptable, with an appearance that it was used.The exact root cause could not be determined from the investigation performed.The returned opened knife was found to have a radius cutting edge that was unacceptable, due to it being used.How and when the radius cutting became unacceptable could not be determined from this evaluation; therefore the root cause cannot be determined.The exact root cause for the damaged knife 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 tips and cutting edge exhibited on the returned opened samples, 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: A-OK OPHTHALMIC 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 ; 8175514979
• MDR Report Key: 12240843
• Report Number: 2523835-2021-00269
• Device Sequence Number: 14335556
• Product Code: HNN
• UDI-Device Identifier: 00380659900020
• UDI-Public: 00380659900020
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2021

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: 06/30/2025
• Device Catalogue Number: 8065990002
• Device Lot Number: 13M51F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 11/19/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/13/2021; 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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