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

Catalog Number 8065751763

Device Problems Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)

Patient Problems Eye Burn (2523); Eye Burn (2523); Fluid Discharge (2686); No Code Available (3191)

Event Date 03/18/2019

Event Type  Injury  

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 during a left eye cataract procedure, during sculpting they noticed resistance in the handpiece.White foamy material from the lens was noted.The surgeon irrigated the anterior chamber with saline and replaced the phacoemulsification tip sleeve.There was no improvement.A corneal burn was noticed in the wound.The handpiece was exchanged, the cataract was removed and the intraocular lens was implanted.A noticeable wound leak was present.Three corneal sutures were placed to close the wound.

Manufacturer Narrative

The customer did not request service for the system.The phacoemulsification handpiece was not returned for evaluation.The phacoemulsification handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.(b)(4).

Manufacturer Narrative

The system was examined.The company representative was unable to find anything that would have contributed to the reported issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The phacoemulsification (phaco) handpiece was returned for evaluation.However, upon visual assessment of the returned sample, it was revealed that the handpiece was third party repaired.As such, functional testing was not performed on this handpiece (per our procedure).The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.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: 8496979
• MDR Text Key: 141427264
• Report Number: 2028159-2019-00647
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/21/2019; 12/17/2019
• Supplement Dates FDA Received: 06/11/2019; 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR