MAUDE Adverse Event Report: CARL ZEISS MEDITEC FEMTOSECOND LASER (SMILE); FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

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

Patient Problems Dry Eye(s) (1814); Inflammation (1932); Fibrosis (3167)

Event Date 05/04/2018

Event Type  Injury  

Event Description

Severe xerophthalmia post refractive correction surgery (smile method) just for helping to reduce the complications of this method.Thanks by the way.

• Brand Name: FEMTOSECOND LASER (SMILE)
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC
• MDR Report Key: 7739176
• MDR Text Key: 115823435
• Report Number: MW5078745
• Device Sequence Number: 0
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 48