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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Halo (2227); Depression (2361)

Event Date 03/28/2023

Event Type  Injury  

Event Description

A patient submitted voluntary report mw5149793 and reported the following: "relex smile in both eyes with -4.5 myopia.Corneal neuropathic pain, dry eyes, starbursts, halos, glare, ghosting after surgery.Vision is very bad.Almost not able to continue career as it consultant.No surgeon is able to help or doesn't want to.Life ruined.Not enough information about the complications of those surgeries.I need therapy after surgery for mental health and depression.".

Manufacturer Narrative

The voluntary report does not identify the name or the contact information of the patient or the doctor.Therefore, the respective device 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 procedure which could explain the mentioned side effects.

• 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: 18888549
• MDR Text Key: 337474720
• Report Number: 9615030-2024-00007
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 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): Disability; Other
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White