MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the device evaluation results the visumax worked within specification.The manufacturer determined that the root cause of the event is user error (decentration).Checking of the pre-op and the post-op topography data shows that the ablation was clearly shifted to the right (os).Review of the treatment video confirmed that there is a decentration.The decentered smile explains the visual outcome.Proper preparation of the patient and aspects that require additional attention as well as further safety and warning instructions are described in the user manual.
Event or Problem Description
A health care professional (hcp) reported that a patient who went through a smile procedure lost 3 lines of the best corrected visual acuity (bcva).The patient's one eye is 20/20 but the other eye's bcva is 20/50.

• Brand Name: VISUMAX
• Common Device Name: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• MDR Report Key: 12380094
• Report Number: 9615030-2021-00017
• Device Sequence Number: 14437045
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)161101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-1345-518
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR