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

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Unspecified Infection (1930); Keratitis (1944); Blurred Vision (2137); Visual Impairment (2138); Halo (2227)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

The side effects described by the patient is documented as a potential risk of the smile procedure in the visumax instruction for use.The voluntary report received by czmi does not contain any product information such as serial number or contact information of the patient, physician or user facility.Therefore, the manufacturer is unable to perform a detailed investigation or confirm the alleged injury.

Event Description

Carl zeiss meditec, inc.Received from the fda a voluntary event report mw5086435, which was submitted by a patient.In the voluntary report, the patient reported experiencing various side effects post refractive correction surgery using the visumax laser system.The patient did not allege a device malfunction.

• Brand Name: VISUMAX LASER KERATOME
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, 7745 ; GM 7745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 8742088
• MDR Text Key: 149486488
• Report Number: 9615030-2019-00009
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other