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

Lot Number N/A

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

Patient Problem Dry Eye(s) (1814)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

The available information was reviewed and no matching complaint was identified with the event reported on the voluntary event report mw5078745.No additional information about patient, device, or health care professional (hcp) could be obtained from the voluntary event report or the maude database.Xerophthalmia or dry eye is documented as a potential risk of the smile procedure in the visumax instruction for use.

Event Description

Carl zeiss meditec, inc.Received from the fda a voluntary event report mw5078745, which was submitted by a health care professional (hcp).In the voluntary report, the hcp reported that a patient experienced severe xerophthalmia post refractive correction surgery using the visumax laser system.The physician 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, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 7866702
• MDR Text Key: 119927851
• Report Number: 9615030-2018-00005
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• 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): Other