MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER ULTRASHARP KNIFE; KNIFE, OPHTHALMIC

Catalog Number	681.05
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample has been received by 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 during a cataract extraction surgery, an ophthalmic knife blade was found to be dull when the surgeon attempted to make the paracentesis.There was no report of any patient harm.Additional information has been requested.Additional information received further clarified that an alternate knife was obtained in order to complete the procedure.It was confirmed that there was no harm to the patient.
Additional Manufacturer Narrative
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.Sample received in opened original packaging without cover foil.The sample was visually inspected with the aid of a photomicroscope with various magnifications.Some residuals are visible.After cleaning device was reviewed with a technical expert from manufacturing.It was found that the blade meets the specifications.No damage visible on the blade.Device was 100% tested during manufacturing process.The customer¿s complaint was not confirmed.The product was found to be within specifications.No corrective actions are required, because there is no indication of a malfunction.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ULTRASHARP KNIFE
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 12053298
• Report Number: 3003398873-2021-00041
• Device Sequence Number: 3647767
• Product Code: HNN
• UDI-Device Identifier: 07612717000063
• UDI-Public: 07612717000063
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 02/29/2024
• Device Catalogue Number: 681.05
• Device Lot Number: F175500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1