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 Problems Foreign Body Sensation in Eye (1869); Keratitis (1944); Blurred Vision (2137)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.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 diffuse lamellar keratitis right greater then left three days following lasik treatment.The patient reported a foreign body sensation and computer distance vision is blurry.The topical steroids were increased.Additional information requested.There are two related reports for this patient.This report addresses the patient's right 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.The laser was successfully verified prior to the treatment.The root cause could not be identified conclusively.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: 8160841
• MDR Text Key: 130231983
• Report Number: 3003288808-2018-01935
• 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: 02/06/2019

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: 11/19/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR