MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME; CYSTOTOME

Catalog Number	8065425120
Medical Device Problem Codes	Dull, Blunt (2407); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
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
A nurse reported that during a cataract surgery an ophthalmic cystotome and cannula had burr on it and it could not penetrate through the capsular bag.The procedure was completed with another product.There was no patient harm reported.
Additional Manufacturer Narrative
Two opened cystitome and cannula (c&c) cannulas in bodies and lids were received, the samples were visually inspected and found to be nonconforming, the cannulas had damaged tips.The samples were visually inspected for cannula burr and were found to be conforming.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The returned samples are visually non-conforming with the tips of the cystitome damaged; therefore, a blunt needle was confirmed; however, how and when the tips of the cystitome became damaged could not be determined and a root cause for the reported issue could not be determined.The samples were found to be conforming for the report of burred tips, therefore a burred tip as described in the complaint was not confirmed and the root cause could not be confirmed.The cannulas were found conforming for burrs; however, the exact root cause for the damaged tip samples is unknown, therefore specific action with regards to this complaint cannot be taken.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.Any nonconformance, such as the damaged tips exhibited on the returned opened samples is removed from the lot and scrapped.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME
• Common Device Name: CYSTOTOME
• 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: 16012966
• Report Number: 2523835-2022-00463
• Device Sequence Number: 7341094
• Product Code: HNY
• UDI-Device Identifier: 00380654251202
• UDI-Public: 00380654251202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 05/25/2023

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 Catalogue Number: 8065425120
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Sex: Unknown