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 Problem Eye Injury (1845)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer reviewed on-site service documentation which confirmed that the device was working within specification.The investigation has not identified any abnormality or product deficiency related to the incident.The manufacturer evaluated the log files and treatment protocols from the device.The data indicated that the laser energy value was set very high at 40 (200 nj) during the visumax smile treatment.The user manual (ifu 000000-1345-518-doks-sm-gb-160514, page 29) advises the hcp that changes in parameters should only be made in consultation with the attending application specialist.The user manual also cautions the hcp that the parameters may have an impact on the clinical results , e.G., post-operative visual acuity.

Event Description

The health care professional (hcp) from (b)(6) reported a bad refractive outcome.The patient lost more than two lines of bscva (best-corrected visual acuity) after visumax smile treatment.The hcp made a decision to refer the patient to another hcp.The second hcp re-treated this patient on (b)(6) 2017.The patient's post-operative ucva (uncorrected visual acuity) after the second treatment was 6/6 od and 6/12 os.All pertinent information available to carl zeiss meditec has been submitted.

• 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: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 6645787
• MDR Text Key: 77703494
• Report Number: 9615030-2017-00010
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• 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: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2016
• 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; Required Intervention
• Patient Age: 47 YR