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 Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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 physician reported during setup that aspiration issue of an ophthalmic polymer tip occurred.The surgery was performed and completed after replacing the product with another one.The procedure type was unknown.There was no patient impact.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.One opened polymer the irrigation aspiration (i/a) bimanual set in a tray in a blister was received for the report of an aspiration issue.The sample was visually inspected and found to be non-conforming with the purple aspiration handpiece observed to have foreign material that was clear and orange/brown in color at the port hole of the i/a tip, the head of i/a tip and on the metal cannula below the gray over mold i/a tip.The particle analysis found the foreign material to most closely match viscoelastic.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 investigation conducted a non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The particle analysis found the foreign material to most closely match viscoelastic.Viscoelastic is not a material that is used in the manufacturing process of the disposable handpiece.How and when the viscoelastic got on it the irrigation aspiration (i/a) tip cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.Based on the evaluation of the information received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All handpieces are 100% visually inspected prior to being released from the manufacturing facility.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted 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: 23630430
• Report Number: 2523835-2025-01232
• Device Sequence Number: 21405490
• Product Code: KYG
• UDI-Device Identifier: 00380657519224
• UDI-Public: (01)00380657519224(17)270228(11)250321(10)17ALAC
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 8065751922
• Device Lot Number: 17ALAC
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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