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 Blurred Vision (2137)

Event Date 06/20/2019

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

Event Description

An optometrist reported a surgeon treated the incorrect prescription on the patient's left eye.The patient complained of blurred vision post-operatively.An enhancement procedure was performed.

Manufacturer Narrative

Logfile review shows data for patient was entered with +2.5 instead of +5.5.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 treatment date.User entered wrong data.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: 8776734
• MDR Text Key: 150583594
• Report Number: 3003288808-2019-00705
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR