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

Catalog Number 000000-1345-518

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

Patient Problems Tissue Damage (2104); Visual Impairment (2138)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

Based on review of system log files and the videos captured from each of the surgeries performed, the visumax device worked according to specifications.As reported by the hcp, the issue with the patient's vision was a due to the other hcp's action (i.E.Creation of a "third cut") while removing the lenticule during the smile surgery.A device evaluation was not performed since there was no allegation of a device malfunction.

Event Description

On (b)(6) 2018, a healthcare professional (hcp) initiated a circle surgery to improve the visual acuity of a patient that previously underwent a smile surgery performed by a different hcp from the same facility with the same visumax device.Prior to the circle surgery, it was reported that the patient had a visual acuity of 8/10 with refraction on the right eye (od) that cannot be improved with correction.During the circle surgery, after having created the circle cut and during the removal of the flap, the surgeon found that the corneal stroma on the visual axis had been damaged during the smile surgery (by creation of a "third cut") by the other hcp from the same facility.Therefore, the hcp decided to stop the circle surgery.Two days after the circle surgery, the patient's visual acuity was checked by the hcp and reported to be 5/10.The hcp reported that he plans to see the patient again in a month to generate topography images, and perform tomography scans and a slit lamp exam.No further details are known at this time.

• 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 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 8029291
• MDR Text Key: 125866304
• Report Number: 9615030-2018-00010
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1345-518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2014
• 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
• Patient Age: 31 YR