MAUDE Adverse Event Report: LASIK

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

Patient Problem Visual Impairment (2138)

Event Date 06/24/2016

Event Type  Injury  

Event Description

Poor night driving vision as a result of lasik in (b)(6) 2016.Name of the company that makes (or compounds) the product: lasikplus.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2016.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using this product (such as what condition was it supposed to treat): poor vision.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 6311727
• MDR Text Key: 66930262
• Report Number: MW5067753
• Device Sequence Number: 1
• Product Code: OJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BIOTIN SUPPLEMENT; CALCIUM SUPPLEMENT; FISH OIL; GLUCOSAMINE CHONDROITIN. ; OTC MEDS: MULTIVITAMIN; PROBIOTIC SUPPLEMENT; RX MEDS: MIRENA.
• Patient Age: 35 YR
• Patient Weight: 68