MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990601

Device Problem Failure to Sense (1559)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.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.Could potentially lead to injury if arcuates the manufacturer internal reference number is: (b)(4).

Event Description

A customer reported a loss of pupil detection during refractive treatment.Additional information has been requested.

Manufacturer Narrative

During the technical onsite visit the field service engineer (fse) inspected the eyetracker system (camera, sensors, cables and connections) and performed tests.The fse replaced the internal mirror of the eyetracker system.The mirror was worn due to contact with liquids used during surgery.The fse also replaced control panel due to irregular behavior.The system meets specification.The fse advised the customer to avoid contact with critical elements of the equipment performed by using liquids during surgery.The root cause is worn mirror of the eye tracker camera that caused by user handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 8007009
• MDR Text Key: 125126722
• Report Number: 3003288808-2018-01725
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1