MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INTREPID AUTOSERT IOL HANDPIECE, I/A TIP; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED

Catalog Number 8065751012

Device Problems Air Leak (1008); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

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.(b)(4).

Event Description

A surgeon reported that during a cataract with intraocular lens procedure (iol) the irrigation handpiece and tip could not aspirate, there were bubbles and air in the aspiration tubing.The staff attempted to correct the issue by removing and reconnecting the irrigation/aspiration tip however the problem did not resolve.The staff opened another irrigation/aspiration set and the system displayed a system message.The staff closed and reopened the page and the device could be used.There was no patient harm.

Manufacturer Narrative

Additional information is provided.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided, the customer reported event could not be confirmed.The i/a handpiece was not returned for evaluation; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.All i/a handpieces are 100% visually inspected and functionally tested during the manufacturing process.The i/a tip was not returned for evaluation.The i/a tip was packed on (b)(6) 2017.There were (b)(4) paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

No further information was able to be obtained from this customer.However, a probe was returned for evaluation.The i/a tip was packed on september 19, 2017.There were (b)(4) paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.The i/a tip was received for evaluation a visual assessment of the returned sample, showed no obvious nonconformities.No problem was found with the sample.Therefore, the root cause of the reported event cannot be determined conclusively.I/a hp.One opened reusable i/a handpiece was returned for evaluation.A photo was provided with the complaint.A review of the device history record (dhr) traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there was one additional complaint associated with the lot for the reported issue.The handpiece was manufactured in october 2017.A photo returned with the complaint file was reviewed.The photo shows an i/a handpiece with a reusable i/a tip attached.There was no conclusion that could be determined (based on the photo itself).However, the handpiece was visually inspected and was deemed to be conforming.A flow check for occlusion was performed on the handpiece and the testing was deemed acceptable.There was no occlusion present.A vacuum and pressure test was performed on the handpiece and the testing was deemed acceptable.All reusable handpieces are 100% visually inspected and functionally tested during the manufacturing process.The evaluation does not confirm the handpiece could not aspirate.The functional testing was conforming.Possible reasons for poor aspiration are poor tubing connections to a handpiece or machine, poor tip connection to the handpiece, improper machine setting, poor cleaning of a handpiece between uses, or the i/a tip was occluded.The manufacturer internal reference number is: (b)(4).

• Brand Name: INTREPID AUTOSERT IOL HANDPIECE, I/A TIP
• Type of Device: APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7517027
• MDR Text Key: 108494866
• Report Number: 2028159-2018-01021
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K112425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

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 Catalogue Number: 8065751012
• Device Lot Number: 17031407X
• Other Device ID Number: 380657510122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 06/27/2019
• Supplement Dates FDA Received: 08/06/2018; 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; ULTRAFLOW II I/A HANDPIECE
• Patient Outcome(s): Other