MAUDE Adverse Event Report: Alcon Research, LLC - Alcon Precision Device INTREPID Transformer; Unit, phacofragmentation

Catalog Number	8065752885
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the ophthalmic blue tip of the product was found to be broken during setup.No additional procedural details or information regarding patient impact were reported.Follow-up information has been requested; however, it is not available at the time of this report.
Additional Manufacturer Narrative
A sample has been available that has not yet reached 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).

• Brand Name: INTREPID Transformer
• Common Device Name: Unit, phacofragmentation
• 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 ; +1(800)757-9780
• MDR Report Key: 50192441
• Report Number: 2523835-2026-00828
• Device Sequence Number: 14976995
• Product Code: HQC
• UDI-Device Identifier: 00380657528851
• UDI-Public: (01)00380657528851(17)281231(11)260121(10)17WEV2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 8065752885
• Device Lot Number: 17WEV2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 01/21/2026
• 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: CENTURION VS
• Patient Sex: Unknown