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 Corneal Infiltrates (2231)

Event Date 12/26/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

An optometrist reported a patient with multiple sterile infiltrates six days following photo refractive keratectomy.The bandage contact lens was discontinued and the topical steroid was increased and put on a taper.The patient is doing well and recovery seems as expected.Additional information received; the patient was noted to be improving and the patient was feeling well five days following onset.The postoperative instructions were further provided to the patient.At nine days following onset the peripheral infiltrates were resolving, epithelium was intact and the topical steroids was continued as previously instructed.

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.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: 8261422
• MDR Text Key: 133551247
• Report Number: 3003288808-2019-00062
• 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: 12/26/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 02/08/2019
• 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: 21 YR