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

Catalog Number 8065751763

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Macular Edema (1822)

Event Date 06/15/2018

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.(b)(4).

Event Description

A health professional reported that a female patient experienced macular edema in the left eye following a cataract extraction with intraocular lens implant procedure.The intraocular lens was implanted in the capsule bag and surgery was completed without incident.The patient was treated with a nonsteroidal anti-inflammatory eye drop and a diuretic agent.Additional information has been requested and received.This report is being filed for the tenth patient left eye from this facility.

Manufacturer Narrative

Additional information has been provided.The company service representative examined the system and was not able to confirm the reported event.The system was then tested and met all product specifications.The system was manufactured on august 17, 2017.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece was manufactured on september 14, 2017.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7800538
• MDR Text Key: 117697972
• Report Number: 2028159-2018-01753
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION HANDPIECE; DISPOSABLE I/A TIP; EYEFILL OVD; KSSP 21,5D-C307240 IOL; UNSPECIFIED BSS; CENTURION HANDPIECE; DISPOSABLE I/A TIP; EYEFILL OVD; KSSP 21,5D-C307240 IOL; UNSPECIFIED BSS
• Patient Outcome(s): Other
• Patient Age: 72 YR