MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M; MARKER, OCULAR

Model Number X-SPM

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2020

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

Event Description

A customer reported that it was later found that a patient's visual acuity had been unable to be properly adjusted due to axis deviation after insertion of a toric intraocular lens following the guidance displayed by the system.It is unknown if the deviation was caused by the console or the user.The patient will be scheduled to fix the deviation at a later date.Additional information received states the intraocular lens deviation was fixed and the patient has recovered.There are four related reports for this patient.This report addresses patient one and another manufacturer report will be filed for the other patients.

Manufacturer Narrative

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

Manufacturer Narrative

A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Data collection was received and the data was investigated.Based on the data the surgeon operated from a slightly inferior position.The selected temporal orientation on the planning screen does not match this orientation of the eye.Followed by a wrong registration proposal confirmed, this lead to a wrong toric alignment overlay.User error, the surgeon operated from a slightly inferior position, which is not available in the device and an incorrect registration was confirmed/manually set.The manufacturer internal reference number is: (b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Type of Device: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• MDR Report Key: 10211973
• MDR Text Key: 197153176
• Report Number: 3010300699-2020-00002
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998244
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR