MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INFINITI VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751176
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2024
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 physician reported that the shape was defective and a bevel was missing before cataract/vitrectomy combination surgery.The surgery was completed after replacing the product with new one.There was no patient harm reported.
Additional Manufacturer Narrative
Following submission of the initial report, it was determined that the information provided for this event ¿shape was defective, bevel was missing¿ (the event code was phaco tip issue/unacceptable) does not represent a reportable device malfunction and it is not likely that a recurrence would result in serious injury.The initial report was submitted in error.No further reports will be scheduled under mfg report num 2523835-2024-01528.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM, HANDPIECE TIP
• 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 ; 8007579780
• MDR Report Key: 19603743
• Report Number: 2523835-2024-01528
• Device Sequence Number: 15273724
• Product Code: HQC
• UDI-Device Identifier: 00380657511761
• UDI-Public: 00380657511761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021566
• 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): 09/05/2024

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 Catalogue Number: 8065751176
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/05/2024
• 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