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

Model Number N/A

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

Patient Problem Eye Injury (1845)

Event Date 09/21/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 302119288
• Report Number: 9615030-2022-00008
• Device Sequence Number: 1
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR