MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE 200HZ EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infiltration into Tissue (1931); Blurred Vision (2137); Increased Sensitivity (4538)

Event Date 12/08/2020

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

Event Description

A facility representative reported a patient with peripheral infiltrate in the right eye post photo refractive keratectomy.Patient noted blur, light sensitivity.Additional information has been requested.

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received reported the patient¿s symptoms were resolved.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient is doing a lot better.The patient is still slightly light sensitive, but improving.The cornea is well healed.There is a non-visually significant peripheral scar.

Manufacturer Narrative

No serial number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALLEGRETTO WAVE 200HZ EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 11071876
• MDR Text Key: 223592305
• Report Number: 3003288808-2020-00815
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990600
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR