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

Model Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Tear (2050)

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 literature article reported one case of retinal tears occurred post-operatively in conventional phacoemulsification surgery (cps) group, after a cataract surgery.As a prophylaxis of retinal detachment, laser retinopexy was performed in that eye.

Manufacturer Narrative

Following the submission of the initial report, it was discovered that a duplicate medical device report with manufacturer report number 2028159-2021-00984 was submitted relating to this event.All further information pertaining to the event and investigation with manufacturer report number 2028159-2021-00983 will be provided in 2028159-2021-00984.The file related to manufacturer report number 2028159-2021-00983 will be closed.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: 12423788
• MDR Text Key: 269841536
• Report Number: 2028159-2021-00983
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention