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

Catalog Number 8065990739

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Disturbances (2140)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.The device history records (dhr) for the device was reviewed.The associated device was released based on company 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.(b)(4).

Event Description

An optometrist reported a patient with glare and halos of the right eye three months following lasik treatment.Upon examination epithelial basement membrane disorder was noted.Sodium chloride hypertonicity ointment was began at night with pending follow up appointment.Additional information received; there has been some improvement since the last follow up visit.Punctal plugs were inserted, the sodium chloride hypertonicity ointment was continued and artificial tears were began during the day.

Manufacturer Narrative

A review of the technical service on site history showed no abnormalities that could have contributed to this event.The laser was successfully verified prior to the day of treatment.Logfile review shows no abnormalities that could have contributed to reported event.All laser system functions were within specifications at this day.No technical root cause was identified as the product was found to be within specifications.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: 8227196
• MDR Text Key: 132418068
• Report Number: 3003288808-2019-00024
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/15/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR