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); Blurred Vision (2137)

Event Date 12/21/2018

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.No udi required due to this device being 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.(b)(4).

Event Description

An optometrist reported a patient with blurry vision and foreign body sensation upon wakening in the left eye three weeks post lasik.The patient noted it was hard to see when waking up in the morning.Topical steroid dosage was increased.Additional information received stated the visual symptoms were first reported at the one day post-operative visit.A bandage contact lens was placed on the left eye.The symptoms resolved but occurred again approximately three weeks later.

Manufacturer Narrative

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

Event Description

Follow up information received by the doctor stated the patient was seen for follow up and the bandage contact lens was removed in the left eye.The patient is suspected to have floppy eyelid syndrome and that the patient's eyelids are everting while sleeping causing the epithelial defects.

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 and after 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: 8275650
• MDR Text Key: 134028432
• Report Number: 3003288808-2019-00097
• 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,Followup
• Report Date: 03/07/2019

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: 01/11/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 02/14/2019
• Supplement Dates FDA Received: 02/14/2019; 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR