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

Model Number	VISUMAX, MOD. 75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, we received a report that a follow up od surgery was performed on a patient.The patient had underwent a ptk surgery after having smile surgery on (b)(6) 2023.The ptk procedure is an after-treatment and an additional medical intervention which was taken in order to prevent permanent and/or temporary impairment.At present, the patient is still in the recovery period after surgery, and no more treatments have been performed.
Additional Manufacturer Narrative
The issue likely occurred due to the patient's anatomical peculiarities.A device malfunction can be excluded.With the current information, there is no indication of any malfunction of the zeiss device which could have contributed to the reported surgical outcome.
Additional Manufacturer Narrative
It was concluded that a too long exposure time of anesthetics (eye drops) was the root cause for the reported event.This led to a dehydration of the cornea.The cornea shrunk down and the resulting cut was made too deep.Description of changes: field g3: date additional information was received by the manufacturer.Field g6: updated to "follow-up, # 1", checked "30 days".Field h2: selected "additional information".Field h10: added description of changes.

• Brand Name: VISUMAX LASER KERATOME
• 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: 17673869
• Report Number: 9615030-2023-00007
• Device Sequence Number: 6378784
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)221201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: VISUMAX, MOD. 75
• Device Catalogue Number: 000000-2217-569
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: 17 YR
• Patient Sex: Prefer Not To Disclose
• Patient Race: Asian