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 09/10/2019

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

An optometrist reported that the left eye prescription was entered into the system for the right eye.Both eyes were treated with the same prescription.Right eye prescription was entered into the system for the left eye treatment but was caught before treatment.Only the right eye was treated with the wrong prescription.The patient notes that vision in the right eye is blurrier than the left eye.The patient has good comfort.Upon follow up, full distance correction was planned to be corrected with surgery.Procedure was completed.The patient reported fuzzy vision greater in the right eye on one day post-operative visit.Fuzzy vision in the right eye improved with artificial tears.

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.Logfile review showed no abnormalities that could have contributed to reported event.All energy settings were within range and all laser system functions were within specifications at this day.Given the provided information (treatment report and pre-op data) the related treatment could be identified.Logfiles showed the user introduced the refraction for the left eye for the treatment in the right eye.The root cause was wrong data entry by the user.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: 9143586
• MDR Text Key: 162321665
• Report Number: 3003288808-2019-00962
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR