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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Nerve Damage (1979); Pain (1994); Visual Impairment (2138); Halo (2227); Depression (2361); Suicidal Ideation (4429)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

The voluntary report does not identify the name or the contact information of the patient or the doctor.Therefore, the respective devices (femto laser system and excimer laser system) could not be identified or investigated, and a root cause evaluation is not possible.There is no indication that any malfunction occurred during the visumax relex smile® procedure which could explain the mentioned side effects.There is no evidence or indication that for the lasik procedure, a zeiss excimer laser system had been used.There is no information on the devices used for femto-lasik.

Event Description

A patient submitted voluntary report mw5104953.The following was reported: "at first in 2020 i get relex smile on right eye, the extraction of the lenticule was not performed.In 2020 i get femtolasik, during the operation it was painful.Even after 1 year i have all side effects." based on the statement by the patient the relex smile® and femto-lasik procedures resulted in a disability, depression and suicide thoughts.The patient suffers with vitreous floaters, halos, double texts, no focus on details and general poor visual impairment.It can be assumed that there was an adverse event which resulted in a significant damage or disruption in the patient's body structure and quality of life.

• 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 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 18895738
• MDR Text Key: 337569252
• Report Number: 9615030-2024-00006
• Device Sequence Number: 1
• Product Code: OTL
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: 000000-1345-518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Disability
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 88 KG