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

Model Number N/A

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

Patient Problem Abscess (1690)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

The retained samples of the treatment pack, which is an accessory to the visumax product, were checked for any break in the sterile barrier.The results were within specification.No abnormalities were found.Root cause for the staphylococcal infection cannot be determined.Staphylococcal infection can not be caused by the visumax device nor is the infection described as a side effect.

Event Description

A health care professional (hcp) reported that two days after going through a visumax smile procedure, the patient had to be hospitalized due to abscesses on both eyes.The patient had a central abscess on the right eye and a peripheral abscess, more diffused, on the left eye.The patient was diagnosed with a staphylococcal infection and was treated at the hospital.

• 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, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 8421699
• MDR Text Key: 138824868
• Report Number: 9615030-2019-00003
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-1741-582
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 34 YR