MAUDE Adverse Event Report: LENS IMPLANT; INTRAOCULAR LENS

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

Patient Problem Eye Infections (4466)

Event Date 01/26/2022

Event Type  Injury  

Event Description

No product or medical device suspected.Suspected tass on postop day 1 after cataract extraction with iol implant, no lab tests were done.

• Brand Name: LENS IMPLANT
• Type of Device: INTRAOCULAR LENS
• MDR Report Key: 13542048
• MDR Text Key: 285715767
• Report Number: MW5107469
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White