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

Catalog Number 8065990739

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Date 08/03/2018

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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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 patient who was under corrected while undergoing a refractive procedure.It was recognized during the treatment that the axis measurement was incorrect prior to cylinder treatment.The procedure was aborted.The patient has elected to wait for healing and return for additional treatment.

Manufacturer Narrative

Logfile review for the date of treatment shows no abnormalities that could have contributed to reported event.All laser system functions were within specifications during treatments at this day.No technical root cause was identified as the product was found to be within specifications.The most likely root cause is a wrong entry of the refraction 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: 7826833
• MDR Text Key: 118569738
• Report Number: 3003288808-2018-01521
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR