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 Type  Injury  

Event Description

A healthcare professional reported that some pts remained somewhat myopic in the surgery after the measurements were taken with the biometer.This report is for the pt that remained 1 diopter myopic.Add'l info was received from the facility who reported that the event was due to the human error when the biometric probe was used.The facility informed that the reported issue has always been pts' myopization: the biometer measured an axial length slightly smaller than real for all the pts; the pts have never remained hypermetropic.According to the facility's opinion the ophthalmologist applied more pressure than the advisable one with the biometer probe to the pts' eyes when taken the measurements.The facility also informed that they were going to take more care and pay more attention at revision time from now on.No add'l info is expected.This is the fourth of four medical device reports being filled for this event.

Manufacturer Narrative

A service visit has been performed.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when add'l reportable info becomes available.No add'l info is expected.(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: 3891762
• MDR Text Key: 4648525
• Report Number: 2028159-2014-01077
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K842757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• 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: 1.15
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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