MAUDE Adverse Event Report: ICL LENS

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

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 03/15/2016

Event Type  Injury  

Event Description

I was admitted to have an icl surgery in the assigned date.During the surgery in which i had local anesthesia, i felt pressure in the right eye, yet the doctor ignored my complaint.The left eye went out perfectly.After the surgery was done, i was admitted home and not hospitalized for at least 4 hours under the doctor's permission.Again i felt nauseous and vomited twice on the way home.My parents called the doctor to tell him that i was suffering pain in my right eye, but he said it was natural.I stayed home in bed 3 days without revision, during this period, i had a very high iop.I was barely able to move.Ater 3 days, i went to the doctor for revision upon his request.Unfortunately, it was too late cause i already had traumatic mydriasis.And now i am developing cataract and painful right eye.I am now being followed with another ophthalmologist.He said that i need cataract surgery and a clear lens extraction.

• Brand Name: ICL LENS
• Type of Device: ICL LENS
• MDR Report Key: 5646258
• MDR Text Key: 44985068
• Report Number: MW5062182
• Device Sequence Number: 1
• Product Code: MTA
• Reporter Country Code: LE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 73