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

Model Number 8065741076

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Postoperative refraction, unexpected (2642)

Event Type  Injury  

Event Description

A surgeon reported that a few minutes after the measurements, the screen of the system started to flicker for 4 patients.After the intraocular lens (iol) implant surgery these patients had 1 to 3 diopters of residual myopia.He also reported that the event will be permanent for this patient since no additional surgery will be performed.For this patient both eyes were affected.The residual myopia was of -1.00 d for the left eye (os).In surgeon's opinion the device contributed to the event because the calculated lens strength was used as provided by the system.The surgeon also reported that the event was noted by the first time one day after surgery.Additional information has been requested but not received to date.This is one of five medical device reports being filled for this event.This report is for the left eye (os) of the second patient.

Manufacturer Narrative

A service visit was 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 additional reportable information becomes available.Additional information has been requested but not received to date.(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: 4172063
• MDR Text Key: 5159240
• Report Number: 2028159-2014-01855
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K842757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8065741076
• Device Catalogue Number: 8065741076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2003
• 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