MAUDE Adverse Event Report:

Catalog Number N/A

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

Patient Problems Cataract (1766); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

Patient has had implant for 5 years and developed cataracts.Will be having cataract surgery in two weeks.Additional information has been requested for this case.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4).

• Brand Name: UNK
• Type of Device: UNK
• MDR Report Key: 8505691
• MDR Text Key: 141653759
• Report Number: 2023826-2019-00589
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1