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

Catalog Number 8065990631

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported refractive result of a patient's second eye was unsatisfying.Following completion of the treatment for the first eye, sterile cleaning solution apparently dripped in the direction of the laser optics when rinsing with the irrigation cannula.There are multiple related reports for this facility.This report addresses patient 2's right eye and other manufacturer reports will be filed.

Manufacturer Narrative

Device history records (dhr) for the device was reviewed.The associated device was released based on company¿s acceptance criteria.During an onsite visit, a field service engineer (fse) found traces of sterile intraocular irrigating solution visible on the eye tracker mirror.Therefore, eye tracker mirror was exchanged.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: 9902907
• MDR Text Key: 187086604
• Report Number: 3003288808-2020-00251
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990631
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other