MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990739

Device Problems Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Sensation in Eye (1869); Pain (1994); Increased Sensitivity (2065)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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 was out of production prior to the (b)(4) 2014 udi regulation date.(b)(4).

Event Description

An optometrist reported a patient presented with foreign body sensation, pain, and photophobia in the left eye two weeks post lasik.The patient was noted to have a corneal infiltrate at the flap margin.The patient was prescribed an oral antibiotic, topical antibiotic drops, and a topical steroid eye drop.The patient noted their vision is fine.Additional information requested.

Manufacturer Narrative

Additional information provided.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.Logfile review shows no abnormalities that could have contributed to reported event.All energy settings were within range and 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.There is no indication for a product problem which (might have) caused or contributed to the reported event.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: 7902217
• MDR Text Key: 121504888
• Report Number: 3003288808-2018-01586
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: 08/27/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR