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

Catalog Number 8065990601

Device Problem Device Sensing Problem (2917)

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

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).

Event Description

A customer reported difficulty to track pupil during treatment.The eye tracker does not catch the eye at one position so the surgeon had to adjust the patient's head slightly at one angle and then the system started tracking.No patient harm reported.

Manufacturer Narrative

During an onsite visit the fse (field service engineer) checked the machine and found that the mirror is having patches due to difficulty in eye tracking.To fix this issue, the fse replaced the mirror for eye tracker and successfully completed system verification to specification.The root cause could not be determined conclusively.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: 9481118
• MDR Text Key: 177026353
• Report Number: 3003288808-2019-01247
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1