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

Catalog Number 8065751763

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2019

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 customer reported that at the end of a surgical procedure metallic particles were noted on the iris surface and in the anterior chamber of a patient's left eye after using miotic eye drops.The surgeon attempted to remove the particles by using vacuum with a backflush instrument and to clean the anterior chamber during the same procedure.This intervention did not resolve the issue.The patient was not hospitalized and medical intervention was not required.It is currently unknown if the particles have caused any damage.The particles are not expected to resolve and remain in the eye.This is the first of two reports from this facility for this event.

Manufacturer Narrative

One opened probe was received with no tip protector, loose in a piece of bubble wrap, for the report of metallic deposits on the iris surface and in anterior chamber.At the time of sample receipt it was observed that the tubing of the probe was cut and the probe needle was bent.The sample was visually inspected and found to be non-conforming with white foreign material in the port and along the probe needle and orange/brown foreign material on the port face.No metallic foreign material was observed.A photo of the probe have been reviewed by the manufacturing site.The photo of the probe was from a distance, therefore no quality decisions could be made from the photo.A review of the device history record 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 for device component lots traceable to the reported lot number indicates there are no additional complaints associated with the component lots for the reported issue.The sample evaluation did not confirm the presence of metallic foreign material, therefore the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The exact root cause of the foreign material that was observed cannot be determined, however, the most likely root cause is handling at any point after the probe was shipped from the manufacturing site, including use during surgery.No action was taken as the complaint evaluation did not confirm the presence of metallic foreign material and the source for the observed foreign material could not be determined from the evaluation performed.All probes are 100% visually inspected for foreign material, including metallic foreign material.Any non-conformance's found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 9089349
• MDR Text Key: 164900155
• Report Number: 2028159-2019-01715
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: 8065751763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAUSCH & LOMB HORIZONTAL MICRO SCISSOR; CLEARCUT SB INTREPID 2.0 ANG
• Patient Age: 54 YR