MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG SMILE FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Date 02/15/2018

Event Type  Injury  

Event Description

I had smile surgery for both eyes on (b)(6) 2018 by dr (b)(6) at (b)(6) ctr in (b)(6). He told me i had no risks at all and will see well right after surgery. Now i have irregular astigmatism. I see glare, halos and starbursts from light sources during the day and night. I cannot drive in dark roads at night anymore. I have severe dryness in my eyes. Upon consulting a third party i came to know that he had treated an optical zone smaller than my scotopic pupil size. He hadn't even measured my pupil sizes. After surgery, he laughed at me when i told him my symptoms and denied his mistake. He said i have interface fluid that is causing my visual disturbances and i have higher order aberrations (hoas). He offered me lasik to fix it but i refused. When i left a review about the case on facebook, the cancelled my scheduled appts with him and he now refuses to see me. The owner of the clinic also blocked me on whatsapp. P. S: the surgeon himself wears glasses.

• Brand Name: SMILE
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG
• MDR Report Key: 7885076
• Report Number: MW5079848
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 26 YR
• Patient Outcome(s): Other; Disability