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	Eye Injury (1845)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional (hcp) reported that the patient had an uneventful smile procedure of the left eye on (b)(6), 2022.Right eye was slightly overcorrected and an enhancement was performed on (b)(6), 2022, with flap and mel80.Flap creation was perfect and it lifted fine.Hyperopic mel80 ablation was performed immediately after the lift.Once completed, a thin corneal "wafer" or "layer" was noticed in the stromal bed when the flap was repositioned.Two days later, after consulting with another surgeon, the flap was repositioned again with careful attention to the wafer.
Additional Manufacturer Narrative
The most possible root cause is a user error, which is neither due to ergonomic features, nor due to any inadequacy in the information supplied by the manufacturer.Root cause is a wrong planning of the surgeon: in this case the surgeon used lasik for retreatment which was not suitable.Low refraction retreatments are normally done with prk.The rest of stroma is thicker with prk after the redo.If the refraction is too big for a prk treatment the solution would have been a circle opening the smile pocket.

• 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
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 15642280
• Report Number: 9615030-2022-00008
• Device Sequence Number: 20253360
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Unknown