MAUDE Adverse Event Report: ALCON -IRVINE TECH CTR OCUSCAN RXP; ULTRASONIC PULSED ECHO IMAGING SYS

Model Number 8065741076

Device Problem Incorrect Measurement (1383)

Patient Problem Postoperative refraction, unexpected (2642)

Event Type  Injury  

Manufacturer Narrative

A service visit has been performed.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary with 21 cfr 803.56 when additional reportable info becomes available.No additional info is expected.(b)(4).

Event Description

A healthcare professional reported that some patients remained somewhat myopic in the surgery after the measurements were taken with the biometer.This report is for the pt that remained 3 diopter myopic.Additional info was received from the facility who reported that the event was due to a human error when the biometric probe was used.The facility informed that the report issue has always been patients' myopization: the biometer measured an axial length slightly smaller than real for all the patients; the patients 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 pt's 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 additional info is expected.This is the first of four medical device reports being filed for this event.

• Brand Name: OCUSCAN RXP
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYS
• Manufacturer (Section D): ALCON -IRVINE TECH CTR; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer (Section G): ALCON -IRVINE TECH CTR; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3891758
• MDR Text Key: 19399190
• Report Number: 2028159-2014-01076
• 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