MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER OCUSCAN RXP; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number 8065741076

Device Problem Incorrect Measurement (1383)

Patient Problem Postoperative refraction, unexpected (2642)

Event Date 01/01/2014

Event Type  Injury  

Event Description

A surgeon reported that the system provided inaccurate biometry measurements resulting in a pt being left 10 diopters off the expected outcome.Additional info has been requested.

Manufacturer Narrative

A service visit has been performed and the investigation is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable info becomes available.(b)(4).

• Brand Name: OCUSCAN RXP
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3834439
• MDR Text Key: 4393775
• Report Number: 2028159-2014-00818
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K842757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065741076
• Device Catalogue Number: 8065741076
• Other Device ID Number: 1.13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other