MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751922
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during irrigation aspiration (i/a) step of a cataract procedure the irrigation aspiration handpiece did not build up vacuum.The procedure was completed with another i/a handpiece there was no patient harm reported.
Additional Manufacturer Narrative
One opened bimanual handpiece was received for the report of does not build up vacuum.The returned sample was visually inspected and deemed nonconforming.White foreign material was observed in the port hole of the aspiration handpiece.The irrigation handpiece was found to be conforming.The foreign material was sent for analysis.An occlusion/leakage test was performed on the aspiration handpiece.The handpiece was found to be conforming.An occlusion/leakage test was no performed on the aspiration handpiece due to the foreign material blocking the tip.The foreign material was sent for analysis.Particle analysis found the foreign material to be dried salts.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be occluded.The foreign material was best found to match dried salts.How and when the ia tip became occluded with dried salts cannot be determined from this evaluation; therefore a root cause cannot be determined for the complaint as described by the customer.Possible contributing factor of the dried salts is surgical material from during use in surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All handpieces are 100% visually inspected prior to being released from the manufacturing facility.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: INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: 18815407
• Report Number: 2523835-2024-00205
• Device Sequence Number: 8531906
• Product Code: KYG
• UDI-Device Identifier: 00380657519224
• UDI-Public: 00380657519224
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 03/31/2025
• Device Catalogue Number: 8065751922
• Device Lot Number: 15KJ65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/26/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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.; SURGICAL PRODUCT, UNSPECIFIED.
• Patient Sex: Unknown