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

Catalog Number 8065990739

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/24/2019

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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.The device history record (dhr) for the device has been reviewed.The associated device was released based on company¿s acceptance criteria.The manufacturer internal reference number is: (b)(4).

Event Description

A center director reported that a patient was treated for -0.50 astigmatism instead of -1.50.The patient was retreated later the same day with a -1.00.The patient's vision was good on one day follow up visit.The patient was released from care.

Manufacturer Narrative

A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to treatment date.Log file review showed no abnormalities that could have contributed to the reported event.All energy settings were within range and all laser system functions were within specifications at this day.All treatment parameters were manually inserted by user and need to be checked and confirmed.The root cause could be determined as 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: 9069299
• MDR Text Key: 160304126
• Report Number: 3003288808-2019-00897
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990739
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR