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

Catalog Number 8065753075

Device Problems Appropriate Term/Code Not Available (3191); Suction Failure (4039)

Patient Problems Corneal Edema (1791); Unspecified Eye / Vision Problem (4471)

Event Date 06/02/2021

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 physician reported that an ophthalmic operating console had no aspiration and presented a system message during a cataract surgery.The surgery was completed by using a back up console.The patient experienced corneal edema with low visual acuity.Eye drops were prescribed and the symptoms were resolved.

Manufacturer Narrative

The system was examined.And the company representative, was not able to replicate anything that would have contributed to the reported event(s).The system was tested.And found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa 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.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12333280
• MDR Text Key: 267019905
• Report Number: 2028159-2021-00910
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: TBD
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753075
• Device Lot Number: 13R7XH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR