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 Headache (1880); Intraocular Pressure Increased (1937); Pain (1994); Visual Impairment (2138); Discomfort (2330)

Event Date 09/17/2018

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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.No udi required due to this device being out of production prior to the september 24, 2014 udi regulation date.(b)(4).

Event Description

An optometrist reported a patient that complained of pressure around the left eye, headache, lots of pain and discomfort, blurred vision, and decreased visual acuity four days post lasik.The optometrist stated they had the patient hold their nose and blow which relieved the discomfort.Additional information has been requested.

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.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: 7973540
• MDR Text Key: 123959850
• Report Number: 3003288808-2018-01680
• 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: 02/07/2019

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: 09/25/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR