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); Increased Sensitivity (2065)

Event Date 01/28/2019

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

Event Description

A facility representative reported a patient with suspected diffuse lamellar keratitis (dlk) in the left eye two days post lasik.There was diffuse granular appearance.The patient complained of foreign body sensation, glare, photophobia and light sensitivity.Topical steroid dosage was increased to every hour and an antibiotic drop was prescribed.Follow up information received stated the patient's symptoms have resolved and the patient is healing well.

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 treatment date.The root cause could not be determined 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: 8339609
• MDR Text Key: 136168947
• Report Number: 3003288808-2019-00167
• 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: 03/14/2019

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: 01/29/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR