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 Loss of Vision (2139)

Event Date 08/15/2019

Event Type  Injury  

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 (b)(4) 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).

Event Description

An optometrist reported a patient that was treated with the wrong axis in both eyes during photorefractive keratectomy.The patient is unable to see.The patient will be seen in follow up at a later date as well as a possible enhancement.Additional information requested.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.

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 and after the day of treatment.Logfile review shows no abnormalities, all laser system functions were within specifications at this day.Logfile review can confirm wrong axis treated.Patient treated with wrong axis.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: 8975983
• MDR Text Key: 156941889
• Report Number: 3003288808-2019-00886
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR