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

Model Number	X-SPM-03
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr : 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 or Problem Description
A physician reported that a false authentication of digital marker microscope (dmm) had occurred.The doctor inserted the iol on the axis as instructed, after dmm authentication.Postoperatively, axis misalignment was found, and even though dmm was authenticated again, the same axis as the first time was displayed.The doctor gave up (using) the dmm, authenticated with another planner, and fixed the iol position according to the displayed axis, and completed the surgery.Reporter informed that there's no patient harm.Reporter informed that there may be a possibility of misauthentication by verion.The reporter thought that the measured value of verion, before the surgery, was also wrong.
Additional 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 investigated.Based on this data it was found that the set microscope orientation was not optimal.The surgeon manually confirmed registration of 8 degrees, which was not valid.For the set microscope orientation, a valid registration based on matching scleral vessels was possible at 20 degrees, which is outside the working range of the system verion.Different microscope orientation required.Root cause is user error.Incorrect microscope orientation and registration angle confirmed by the surgeon.The manufacturer internal reference number is: (b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Common Device Name: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• MDR Report Key: 12259448
• Report Number: 3010300699-2021-00002
• Device Sequence Number: 11947802
• Product Code: HLG
• UDI-Device Identifier: 00380659982705
• UDI-Public: 00380659982705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X-SPM-03
• Device Catalogue Number: 8065998270
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORA SYSTEM 2000; VERION REFERENCE UNIT; ORA SYSTEM 2000; VERION REFERENCE UNIT
• Patient Age: 72 YR