MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 8065741076

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported experiencing incorrect biometry measurements.An alternate system was used.

Manufacturer Narrative

There is no sample returned and no further information that indicates any system nonconformities.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With the information obtained, the root cause could not be determined at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9765595
• MDR Text Key: 184514267
• Report Number: 2028159-2020-00156
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K844686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065741076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1