MAUDE Adverse Event Report: LENS IMPLANT; INTRAOCULAR LENS

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

Patient Problems Pain (1994); Visual Impairment (2138); Loss of Vision (2139)

Event Date 06/21/2019

Event Type  Injury  

Event Description

Laser was used for cataract surgery on (b)(6) 2019 pain immediately following the surgery and occasional pain as of today (b)(6) 2019.Difficult to focus due to watering in eye.Loss of eye sight.Surgeon said everything was fine and dismissed me.Cataract removal.Fda safety report id# (b)(4).

• Brand Name: LENS IMPLANT
• Type of Device: INTRAOCULAR LENS
• MDR Report Key: 9342766
• MDR Text Key: 167326369
• Report Number: MW5091173
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2019

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?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 104