MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

A customer reported that metal piece came out during surgery.The surgery was completed without product replacement.There was no patient harm.

Manufacturer Narrative

Additional information provided in d.10., g.1., g.2., h.3., h.6., and h.10.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.An opened phaco tip and a foreign material adhere between tape were returned for evaluation for the report of metal piece came out during ultrasonic oscillation.Two photos attached to the parent complaint were reviewed by the investigation site.Photo 1 contains four different views of a phaco tip and its features: cannula outside diameter, bevel, bevel outside diameter, bevel inside diameter, threads and back face.Damage is observed in the phaco tip features.Photo 2 contains an unknown foreign material.The phaco tip was visually inspected and deemed nonconforming, clear foreign material present along the whole phaco tip.Several damage in nut consistent with use.Wear on the flange, nut and threads.Damage on bevel consistent with use.Foreign material adhere between tape.The foreign material returned between tape was sent to particle lab for analysis.The foreign material was isolated and analyzed.The foreign material was determined to be composed of titanium and other elements.The presence of these elements along with the visual characteristics suggest the particle to be metallic.Phaco tips are manufacture from titanium.The complaint evaluation confirm the foreign material to be metallic and compose of titanium.Although phaco tip are manufacture from titanium, the visual inspection was found damage consistent with use along the phaco tip.The most likely sources of metal is from the phaco tip being hit by another object during surgery, reuse of the phaco tip, or during the manufacturing machining process to not remove a metal spiral from the inside diameter of the phaco tip.How and when the foreign material became present cannot be determined from this evaluation.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9182484
• MDR Text Key: 172053443
• Report Number: 2028159-2019-01842
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2020
• Device Model Number: JAPAN
• Device Catalogue Number: 8065751143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KELMAN PHACO TIP